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Recall Observatory FDA recall evidence

Device product

Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

Z-2317-2015

July 02, 2015

Class I

Product summary

Firm
Cook Inc.
Event
Event 71692
Status
Terminated
Classification
Class I
Quantity
451550
Official record key
device-enforcement:Z-2317-2015

Official wording

Reason: Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.

Code information: All Lots of following Product numbers: HNBR4.0-35-100-P-NS-0, HNBR4.0-35-100-P-NS-C1, HNBR4.0-35-100-P-NS-C2, HNBR4.0-35-100-P-NS-CANADA-041480, HNBR4.0-35-100-P-NS-DAV, HNBR4.0-35-100-P-NS-H1, HNBR4.0-35-100-P-NS-JB1, HNBR4.0-35-100-P-NS-JB2, HNBR4.0-35-100-P-NS-JB3, HNBR4.0-35-100-P-NS-JIM, HNBR4.0-35-100-P-NS-KMP, HNBR4.0-35-100-P-NS-MPA, HNBR4.0-35-100-P-NS-O1, HNBR4.0-35-100-P-NS-SIM1, HNBR4.0-35-100-P-NS-SIM2, HNBR4.0-35-100-P-NS-SIM3, HNBR4.0-35-100-P-NS-VERT, HNBR4.0-35-100-P-NS-VTK, HNBR4.0-35-100-P-NS-WNBG, HNBR4.0-35-125-P-NS-0, HNBR4.0-35-125-P-NS-DAV, HNBR4.0-35-125-P-NS-H1, HNBR4.0-35-125-P-NS-JB1, HNBR4.0-35-125-P-NS-JB2, HNBR4.0-35-125-P-NS-MPA, HNBR4.0-35-125-P-NS-SIM2, HNBR4.0-35-125-P-NS-VERT, HNBR4.0-35-125-P-NS-VTK, HNBR4.0-35-125-P-NS-WNBG, HNBR4.0-35-40-P-NS-KMP, HNBR4.0-35-65-P-NS-0, HNBR4.0-35-65-P-NS-C1, HNBR4.0-35-65-P-NS-C2, HNBR4.0-35-65-P-NS-C3, HNBR4.0-35-65-P-NS-DAV, HNBR4.0-35-65-P-NS-H1, HNBR4.0-35-65-P-NS-JB1, HNBR4.0-35-65-P-NS-KMP, HNBR4.0-35-65-P-NS-MPA, HNBR4.0-35-65-P-NS-RC1, HNBR4.0-35-65-P-NS-RC2, HNBR4.0-35-65-P-NS-RDC, HNBR4.0-35-65-P-NS-RIM, HNBR4.0-35-65-P-NS-SIM1, HNBR4.0-35-65-P-NS-SIM2, HNBR4.0-35-80-P-NS-C1, HNBR4.0-35-80-P-NS-C2, HNBR4.0-35-80-P-NS-JL2, HNBR4.0-35-80-P-NS-JL2.5, HNBR4.0-35-80-P-NS-JL3, HNBR4.0-35-80-P-NS-JR1, HNBR4.0-35-80-P-NS-JR2, HNBR4.0-35-80-P-NS-JR3.5, HNBR4.0-35-80-P-NS-RH, HNBR4.0-35-80-P-NS-RLG, HNBR4.0-35-80-P-NS-VS, HNBR4.0-35-80-P-NS-VS1, HNBR4.0-35-80-P-NS-VS2, HNBR4.0-35-80-P-NS-VS3, HNBR4.0-NT-100-P-NS-H1, HNBR4.0-NT-80-P-NS-RC1, HNBR4.0-NT-80-P-NS-RIM, HNBR4.0-NT-80-P-NS-RLG, HNBR4.1-35-100-P-NS-0, HNBR4.1-35-100-P-NS-C1, HNBR4.1-35-100-P-NS-C2, HNBR4.1-35-100-P-NS-DAV, HNBR4.1-35-100-P-NS-H1, HNBR4.1-35-100-P-NS-JB1, HNBR4.1-35-100-P-NS-JB2, HNBR4.1-35-100-P-NS-JB3, HNBR4.1-35-100-P-NS-KMP, HNBR4.1-35-100-P-NS-MPA, HNBR4.1-35-100-P-NS-O1, HNBR4.1-35-100-P-NS-SIM1, HNBR4.1-35-100-P-NS-SIM2, HNBR4.1-35-100-P-NS-SIM3, HNBR4.1-35-100-P-NS-VERT, HNBR4.1-35-100-P-NS-WNBG, HNBR4.1-35-110-P-NS-JB1, HNBR4.1-35-110-P-NS-JB2, HNBR4.1-35-110-P-NS-WNBG, HNBR4.1-35-120-P-NS-JB2, HNBR4.1-35-130-P-NS-DAV-T, HNBR4.1-35-40-P-NS-KMP, HNBR4.1-35-65-P-NS-C1, HNBR4.1-35-65-P-NS-C2, HNBR4.1-35-65-P-NS-DAV, HNBR4.1-35-65-P-NS-H1, HNBR4.1-35-65-P-NS-JB1, HNBR4.1-35-65-P-NS-KMP, HNBR4.1-35-65-P-NS-LEV1, HNBR4.1-35-65-P-NS-MPA, HNBR4.1-35-65-P-NS-RC1, HNBR4.1-35-65-P-NS-RC2, HNBR4.1-35-65-P-NS-RDC, HNBR4.1-35-65-P-NS-RIM, HNBR4.1-35-65-P-NS-SHK1.0, HNBR4.1-35-65-P-NS-SIM1, HNBR4.1-35-75-P-NS-CHG-D, HNBR4.1-35-80-P-NS-C1, HNBR4.1-35-80-P-NS-C2, HNBR4.1-35-80-P-NS-JL2, HNBR4.1-35-80-P-NS-JL2.5, HNBR4.1-35-80-P-NS-JL3, HNBR4.1-35-80-P-NS-JR1, HNBR4.1-35-80-P-NS-JR2, HNBR4.1-35-80-P-NS-JR3.5, HNBR4.1-35-80-P-NS-RC1, HNBR4.1-35-80-P-NS-RH, HNBR4.1-35-80-P-NS-RLG, HNBR4.1-35-80-P-NS-VS, HNBR4.1-35-80-P-NS-VS2, HNBR4.1-NT-100-P-NS-H1, HNBR4.1-NT-80-P-NS-C1, HNBR4.1-NT-80-P-NS-RC1, HNBR4.1-NT-80-P-NS-RH, HNBR4.1-NT-80-P-NS-RIM, HNBR4.1-NT-80-P-NS-RLG, HNBR5.0-35-65-P-NS-RUC, HNBR5.0-35-90-P-NS-RUC

Distribution pattern: Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.