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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74010

14 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 15, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cook Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

14 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 14

Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic

Z-2610-2016
Recall number
Z-2610-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
2,662,505

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog prefixes HNBR5.0 and HNBR6.0 Catalog/product number; Global/order number HNBR5.0-35-100-P-NS-0 G09916 HNBR5.0-35-100-P-NS-C1 G08623 HNBR5.0-35-100-P-NS-C2 G08796 HNBR5.0-35-100-P-NS-CANADA-041480 G12570 HNBR5.0-35-100-P-NS-DAV G08699 HNBR5.0-35-100-P-NS-FC3 G11204 HNBR5.0-35-100-P-NS-H1 G08421 HNBR5.0-35-100-P-NS-H3 G08918 HNBR5.0-35-100-P-NS-HN1 G09741 HNBR5.0-35-100-P-NS-HN4 G08917 HNBR5.0-35-100-P-NS-HNK1 G27811 HNBR5.0-35-100-P-NS-JB1 G08472 HNBR5.0-35-100-P-NS-JB2 G08809 HNBR5.0-35-100-P-NS-JB3 G08577 HNBR5.0-35-100-P-NS-MAN G08511 HNBR5.0-35-100-P-NS-MIK G11652 HNBR5.0-35-100-P-NS-MPA G11468 HNBR5.0-35-100-P-NS-SIM1 G08471 HNBR5.0-35-100-P-NS-SIM2 G08422 HNBR5.0-35-100-P-NS-SIM3 G08597 HNBR5.0-35-100-P-NS-VERT G11483 HNBR5.0-35-100-P-NS-WAIKATO G13803 HNBR5.0-35-100-P-NS-WNBG G08805 HNBR5.0-35-125-P-NS-C2 G12899 HNBR5.0-35-125-P-NS-C-PS G31970 HNBR5.0-35-125-P-NS-DAV G11375 HNBR5.0-35-125-P-NS-H1 G13258 HNBR5.0-35-125-P-NS-SIM2 G11658 HNBR5.0-35-125-P-NS-VANSCHIE1 G35733 HNBR5.0-35-125-P-NS-VANSCHIE2 G35734 HNBR5.0-35-125-P-NS-VANSCHIE3 G35735 HNBR5.0-35-125-P-NS-VANSCHIE4 G35736 HNBR5.0-35-125-P-NS-VANSCHIE5 G35737 HNBR5.0-35-125-P-NS-VS1 G35974 HNBR5.0-35-125-P-NS-WAIKATO G27813 HNBR5.0-35-40-P-NS-KMP G09751 HNBR5.0-35-40-P-NS-TEGT G13804 HNBR5.0-35-40-P-NS-VANSCHIE1 G31410 HNBR5.0-35-40-P-NS-VANSCHIE2 G31409 HNBR5.0-35-40-P-NS-VANSCHIE3 G31408 HNBR5.0-35-60-P-NS-BELL-1.5 G27815 HNBR5.0-35-65-P-NS-C1 G08441 HNBR5.0-35-65-P-NS-C2 G08442 HNBR5.0-35-65-P-NS-C3 G08443 HNBR5.0-35-65-P-NS-DAV G11414 HNBR5.0-35-65-P-NS-KMP G11458 HNBR5.0-35-65-P-NS-LEV1 G11459 HNBR5.0-35-65-P-NS-LEV2 G11460 HNBR5.0-35-65-P-NS-RC1 G08469 HNBR5.0-35-65-P-NS-RC2 G08470 HNBR5.0-35-65-P-NS-RDC G08596 HNBR5.0-35-65-P-NS-RIM G08444 HNBR5.0-35-65-P-NS-RLG G11380 HNBR5.0-35-65-P-NS-SHK0.8 G32368 HNBR5.0-35-65-P-NS-SIM1 G09853 HNBR5.0-35-65-P-NS-SIM2 G11478 HNBR5.0-35-65-P-NS-VANSCHIE1 G13795 HNBR5.0-35-65-P-NS-VANSCHIE2 G13794 HNBR5.0-35-65-P-NS-VANSCHIE3 G13792 HNBR5.0-35-65-P-NS-VANSCHIE4 G13783 HNBR5.0-35-65-P-NS-VANSCHIE5 G13793 HNBR5.0-35-70-P-NS-DAV G27820 HNBR5.0-35-80-P-NS-C1 G10063 HNBR5.0-35-80-P-NS-C2 G11202 HNBR5.0-35-80-P-NS-CHG4 G13711 HNBR5.0-35-80-P-NS-JR3.5 G11453 HNBR5.0-35-80-P-NS-MPA G09888 HNBR5.0-35-80-P-NS-RDC G13703 HNBR5.0-35-80-P-NS-RIM G12595 HNBR5.0-38-100-P-NS-C1 G09344 HNBR5.0-38-100-P-NS-C2 G09967 HNBR5.0-38-100-P-NS-CK1 G08839 HNBR5.0-38-100-P-NS-DAV G08581 HNBR5.0-38-100-P-NS-H1 G08419 HNBR5.0-38-100-P-NS-H3 G11199 HNBR5.0-38-100-P-NS-HN4 G11200 HNBR5.0-38-100-P-NS-HN5 G09899 HNBR5.0-38-100-P-NS-JB1 G08583 HNBR5.0-38-100-P-NS-JB2 G09654 HNBR5.0-38-100-P-NS-JB3 G11192 HNBR5.0-38-100-P-NS-JIM G11446 HNBR5.0-38-100-P-NS-JR4 G10874 HNBR5.0-38-100-P-NS-KMP G11457 HNBR5.0-38-100-P-NS-MAN G11201 HNBR5.0-38-100-P-NS-MPA G11205 HNBR5.0-38-100-P-NS-MPB G11206 HNBR5.0-38-100-P-NS-RDC G11379 HNBR5.0-38-100-P-NS-RIM G12870 HNBR5.0-38-100-P-NS-SHETTY-050181 G11475 HNBR5.0-38-100-P-NS-SIM1 G08584 HNBR5.0-38-100-P-NS-SIM2 G08420 HNBR5.0-38-100-P-NS-SIM3 G08585 HNBR5.0-38-100-P-NS-TEGT G11193 HNBR5.0-38-100-P-NS-VERT G11484 HNBR5.0-38-100-P-NS-VS2 G11487 HNBR5.0-38-100-P-NS-VS3 G11488 HNBR5.0-38-100-P-NS-VTK G27829 HNBR5.0-38-100-P-NS-WNBG G08582 HNBR5.0-38-110-P-NS-VERT G12128 HNBR5.0-38-120-P-NS-DAV G27830 HNBR5.0-38-125-P-NS-H1 G11378 HNBR5.0-38-125-P-NS-HN2 G11523 HNBR5.0-38-125-P-NS-HN5 G13119 HNBR5.0-38-125-P-NS-JB1 G11726 HNBR5.0-38-125-P-NS-JB2 G11883 HNBR5.0-38-125-P-NS-MPA G12154 HNBR5.0-38-125-P-NS-SIM1 G12072 HNBR5.0-38-125-P-NS-SIM2 G11517 HNBR5.0-38-125-P-NS-VERT G12170 HNBR5.0-38-125-P-NS-VTK G11642 HNBR5.0-38-40-P-NS-0 G24825 HNBR5.0-38-40-P-NS-KMP G09548 HNBR5.0-38-65-P-NS-C1 G08446 HNBR5.0-38-65-P-NS-C2 G08447 HNBR5.0-38-65-P-NS-C3 G08448 HNBR5.0-38-65-P-NS-DAV G11435 HNBR5.0-38-65-P-NS-FINCK-101979 G11437 HNBR5.0-38-65-P-NS-H1 G11395 HNBR5.0-38-65-P-NS-JB1 G11208 HNBR5.0-38-65-P-NS-KMP G09469 HNBR5.0-38-65-P-NS-LEV1 G11194 HNBR5.0-38-65-P-NS-LEV2 G11207 HNBR5.0-38-65-P-NS-LEV3 G11461 HNBR5.0-38-65-P-NS-MPA G11195 HNBR5.0-38-65-P-NS-MPB G11470 HNBR5.0-38-65-P-NS-RC1 G08641 HNBR5.0-38-65-P-NS-RC2 G08642 HNBR5.0-38-65-P-NS-RDC G08578 HNBR5.0-38-65-P-NS-RH G10080 HNBR5.0-38-65-P-NS-RIM G10082 HNBR5.0-38-65-P-NS-RLG G09371 HNBR5.0-38-65-P-NS-SHK1.0 G11476 HNBR5.0-38-65-P-NS-SIM1 G08677 HNBR5.0-38-65-P-NS-SIM2 G08625 HNBR5.0-38-65-P-NS-SIM3 G08849 HNBR5.0-38-65-P-NS-TEGT G11377 HNBR5.0-38-65-P-NS-VERT G11485 HNBR5.0-38-65-P-NS-VS1 G11486 HNBR5.0-38-65-P-NS-VS2 G12715 HNBR5.0-38-65-P-NS-VSC1 G20791 HNBR5.0-38-65-P-NS-VSC2 G20038 HNBR5.0-38-65-P-NS-VSC3 G21042 HNBR5.0-38-75-P-NS-CHG2.5 G27848 HNBR5.0-38-75-P-NS-CHG3 G30040 HNBR5.0-38-75-P-NS-CHG-D G27846 HNBR5.0-38-80-P-NS-C1 G11203 HNBR5.0-38-80-P-NS-C2 G08586 HNBR5.0-38-80-P-NS-CHG2.5 G11430 HNBR5.0-38-80-P-NS-CHG3 G13573 HNBR5.0-38-80-P-NS-CHG-A G13559 HNBR5.0-38-80-P-NS-CHG-B G13560 HNBR5.0-38-80-P-NS-CHG-C G13561 HNBR5.0-38-80-P-NS-CHG-D G13562 HNBR5.0-38-80-P-NS-CHG-E G13563 HNBR5.0-38-80-P-NS-JR1 G13370 HNBR5.0-38-80-P-NS-MIK G09312 HNBR5.0-38-80-P-NS-MK1A G11465 HNBR5.0-38-80-P-NS-MPA G11467 HNBR5.0-38-80-P-NS-MPB G11469 HNBR5.0-38-80-P-NS-RC1 G11530 HNBR5.0-38-80-P-NS-RC2 G11471 HNBR5.0-38-80-P-NS-RDC G12293 HNBR5.0-38-80-P-NS-RH G27852 HNBR5.0-38-80-P-NS-RIM G10028 HNBR5.0-38-80-P-NS-RLG G27853 HNBR5.0-38-80-P-NS-SIM2 G11886 HNBR5.0-38-80-P-NS-VS G11209 HNBR5.0-38-80-P-NS-VS1 G11189 HNBR5.0-38-80-P-NS-VS2 G11190 HNBR5.0-38-80-P-NS-VS3 G11191 HNBR6.0-38-40-P-NS-KMP G27856 HNBR6.0-38-65-P-NS-0 G27858 HNBR6.0-38-65-P-NS-KMP G27860

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 2 of 14

Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

Z-2611-2016
Recall number
Z-2611-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
532,395

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog prefixes HNR5.0 Catalog/product number; Global/order number HNR5.0-35-100-P-10S-0 G09697 HNR5.0-35-100-P-10S-CFP G11264 HNR5.0-35-100-P-10S-PIG G09059 HNR5.0-35-100-P-8S-VCF G31403 HNR5.0-35-100-P-NS-0 G10313 HNR5.0-35-100-ST-10S-0 G09565 HNR5.0-35-100-ST-10S-PIG G09525 HNR5.0-35-110-P-10S-0 G11241 HNR5.0-35-110-P-10S-PIG G11265 HNR5.0-35-65-P-8S-VCF G12129 HNR5.0-35-70-P-10S-0 G09411 HNR5.0-35-70-P-10S-CFP G11262 HNR5.0-35-70-P-10S-PIG G08832 HNR5.0-35-70-P-10S-PIG-RICKETTS-081983 G11280 HNR5.0-35-70-P-4S-PED G11281 HNR5.0-35-70-P-NS-0 G11959 HNR5.0-35-70-ST-10S-0 G09564 HNR5.0-35-70-ST-10S-PIG G09050 HNR5.0-35-80-P-8S-NEFF-CANADA-082098 G11860 HNR5.0-35-90-P-10S-0 G09412 HNR5.0-35-90-P-10S-CFP G11266 HNR5.0-35-90-P-10S-PIG G09408 HNR5.0-35-90-P-10S-PIG-RICKETTS-081983 G11282 HNR5.0-35-90-P-6S-PED G11729 HNR5.0-35-90-P-8S-VCF G12799 HNR5.0-35-90-ST-10S-0 G11641 HNR5.0-35-90-ST-10S-PIG G09197 HNR5.0-38-100-P-10S-0 G11267 HNR5.0-38-100-P-10S-CFP G11268 HNR5.0-38-100-P-10S-PIG G09285 HNR5.0-38-100-P-NS-0 G27874 HNR5.0-38-110-P-10S-0 G09461 HNR5.0-38-110-P-10S-PIG G11269 HNR5.0-38-70-P-10S-0 G11270 HNR5.0-38-70-P-10S-CFP G11271 HNR5.0-38-70-P-10S-PIG G11272 HNR5.0-38-70-P-NS-0 G11289 HNR5.0-38-80-P-10S-OPC G27877 HNR5.0-38-90-P-10S-0 G11273 HNR5.0-38-90-P-10S-CFP G11274 HNR5.0-38-90-P-10S-PIG G11275

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 3 of 14

Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

Z-2612-2016
Recall number
Z-2612-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
332,255

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog prefixes NR5.0 Catalog/product number; Global/order number Centimeter Sizing: NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-70-P-10S-PIG-CSC-20 G31215 NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-100-P-10S-0-CSC-20 G31214 White Vessel Sizing: NR5.0-35-70-P-10S-PIG-WSC G31224 NR5.0-35-70-P-10S-CFP-WSC G31227 NR5.0-35-70-P-10S-0-WSC G31228 NR5.0-35-65-P-6S-VCF-WSC G31229 NR5.0-35-100-P-10S-PIG-WSC G31226 Vessel Sizing: NR5.0-35-90-P-10S-VCF-CAVA G31233 NR5.0-35-90-P-10S-PIG-CAVA G31231 NR5.0-35-70-P-10S-VCF-CAVA G31232 NR5.0-35-70-P-10S-PIG-CAVA G31230

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 4 of 14

Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques

Z-2613-2016
Recall number
Z-2613-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
60,302

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog prefixes/suffixes SCBR5.5-/-SHTL SCBR6.5-/-SHTL Catalog/product number; Global/order number SCBR5.5-35-125-P-NS-H1-SHTL G31129 SCBR5.5-35-125-P-NS-JB1-SHTL G31130 SCBR5.5-35-125-P-NS-JB2-SHTL G36361 SCBR5.5-35-125-P-NS-MPA-SHTL G23697 SCBR5.5-35-125-P-NS-SIM1-SHTL G23699 SCBR5.5-35-125-P-NS-SIM2-SHTL G36360 SCBR5.5-35-125-P-NS-VERT-SHTL G23698 SCBR5.5-35-125-P-NS-VTK-SHTL G36359 SCBR5.5-35-135-P-NS-ANG-SHTL G48154 SCBR5.5-35-150-P-NS-0-SHTL G23705 SCBR5.5-35-150-P-NS-ANG-SHTL G23704 SCBR5.5-35-75-P-NS-ANG-SHTL G48152 SCBR6.5-35-125-P-NS-H1-SHTL G31134 SCBR6.5-35-125-P-NS-JB1-SHTL G31135 SCBR6.5-35-125-P-NS-JB2-SHTL G36364 SCBR6.5-35-125-P-NS-SIM1-SHTL G23701 SCBR6.5-35-125-P-NS-SIM2-SHTL G36363 SCBR6.5-35-125-P-NS-VERT-SHTL G23700 SCBR6.5-35-125-P-NS-VTK-SHTL G36362

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 5 of 14

Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

Z-2614-2016
Recall number
Z-2614-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
298,340

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog prefixes SCBR5.0, SCBR5.5, and SCBR6.5 Catalog/product number; Global/order number SCBR5.0-38-100-P-NS-0 G12005 SCBR5.0-38-100-P-NS-C2 G12008 SCBR5.0-38-100-P-NS-DAV G11996 SCBR5.0-38-100-P-NS-H1 G11991 SCBR5.0-38-100-P-NS-HN4 G23693 SCBR5.0-38-100-P-NS-JB1 G11997 SCBR5.0-38-100-P-NS-JB2 G11998 SCBR5.0-38-100-P-NS-KMP G28535 SCBR5.0-38-100-P-NS-MAN G11999 SCBR5.0-38-100-P-NS-MPA G12002 SCBR5.0-38-100-P-NS-NTR G23695 SCBR5.0-38-100-P-NS-RVC G43120 SCBR5.0-38-100-P-NS-SIM1 G12000 SCBR5.0-38-100-P-NS-SIM2 G11992 SCBR5.0-38-100-P-NS-SIM3 G12001 SCBR5.0-38-100-P-NS-TEGT G23694 SCBR5.0-38-100-P-NS-VERT G12007 SCBR5.0-38-100-P-NS-VTK G13163 SCBR5.0-38-125-P-NS-0 G32366 SCBR5.0-38-125-P-NS-DAV G13413 SCBR5.0-38-125-P-NS-H1 G23696 SCBR5.0-38-125-P-NS-JB1 G13530 SCBR5.0-38-125-P-NS-SIM1 G32369 SCBR5.0-38-125-P-NS-SIM2 G13200 SCBR5.0-38-125-P-NS-TEGT G32367 SCBR5.0-38-125-P-NS-VERT G12168 SCBR5.0-38-125-P-NS-VTK G12082 SCBR5.0-38-40-P-NS-KMP G11993 SCBR5.0-38-65-P-NS-0 G12009 SCBR5.0-38-65-P-NS-C1 G12003 SCBR5.0-38-65-P-NS-C2 G11994 SCBR5.0-38-65-P-NS-C3 G12004 SCBR5.0-38-65-P-NS-DAV G23688 SCBR5.0-38-65-P-NS-H1 G13319 SCBR5.0-38-65-P-NS-KMP G12156 SCBR5.0-38-65-P-NS-LEV1 G12798 SCBR5.0-38-65-P-NS-MPA G23689 SCBR5.0-38-65-P-NS-RC2 G13272 SCBR5.0-38-65-P-NS-RDC G13092 SCBR5.0-38-65-P-NS-RIM G11995 SCBR5.0-38-65-P-NS-SIM1 G12716 SCBR5.0-38-65-P-NS-SIM2 G23691 SCBR5.0-38-65-P-NS-TC G36320 SCBR5.0-38-65-P-NS-TC-BNK G36322 SCBR5.0-38-65-P-NS-TEGT G12179 SCBR5.0-38-80-P-NS-C2 G12006 SCBR5.0-38-80-P-NS-MPA G23692 SCBR5.0-38-80-P-NS-RH G36214 SCBR5.0-38-80-P-NS-VS G13431 SCBR5.0-38-80-P-NS-VS1 G13432 SCBR5.0-38-80-P-NS-VS2 G13433 SCBR5.0-38-80-P-NS-VS3 G13434 SCBR5.5-35-60-P-NS-PATEL G51570 SCBR6.5-35-60-P-NS-PATEL G51571

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 6 of 14

FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for evaluation of tubal patency.

Z-2615-2016
Recall number
Z-2615-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
1,881

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog/product number; Global/order number J-RTAS-100 G51608

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 7 of 14

Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.

Z-2616-2016
Recall number
Z-2616-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
12,595

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog/product number; Global/order number HTPS-100 G36126

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 8 of 14

Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment

Z-2617-2016
Recall number
Z-2617-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
26,076

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog/product number; Global/order number 023565-BT G18074

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 9 of 14

Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.

Z-2618-2016
Recall number
Z-2618-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
52,756

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog prefixes LABS Catalog/product number; Global/order number LABS-100 G08283 LABS-200 G08284 LABS-200-CHP-A G10590

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 10 of 14

Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

Z-2619-2016
Recall number
Z-2619-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
5,020

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog/product number; Global/order number NPAS-100-DAgostino-B-050393 G08403

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 11 of 14

Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

Z-2620-2016
Recall number
Z-2620-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
148,334

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog prefixes / suffixes NPAS-/-SST Catalog/product number; Global/order number NPAS-100-HC-NT-U-SST G52963 NPAS-100-HC-U-SST G52962 NPAS-101-HC-NT-U-SST G23067 NPAS-101-HC-U-SST G23066 NPAS-104-HC-NT-JWG-U-SST G52966 NPAS-104-HC-NT-U-SST G52965 NPAS-104-HC-U-SST G52964 NPAS-105-HC-NT-U-SST G52967 NPAS-108-HC-NT-U-SST G25516 NPAS-120-HC-NT-U-SST G25517 NSSW-4.0-18-NPAS-100-HC-SST G34253

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 12 of 14

Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.

Z-2621-2016
Recall number
Z-2621-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
7,819

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog/product number; Global/order number J-SSG-504000 G17868

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 13 of 14

Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system

Z-2622-2016
Recall number
Z-2622-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
2,606

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog/product number; Global/order number BBFS-100 G26088

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

device · product 14 of 14

White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.

Z-2623-2016
Recall number
Z-2623-2016
Initiated
April 15, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
3,425

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Code information

All Lots. Catalog/product number; Global/order number LMGRF-7.0C-80-MPA-PULM G11164

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.