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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85823

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

Open FDA event record

Event summary

Timeline bucket
July 27, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Datascope Corporation

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

17 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 17

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2831-2020
Recall number
Z-2831-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
1275 kits WW

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000047044 3000049910 3000055308 3000059274 3000064252 3000067462 3000071220 3000077343 3000084725 3000086853 3000087475 3000087971 3000096716 3000097647 3000100873 3000102114 3000109816 3000047042 3000047931 3000049913 3000055307 3000056433 3000059275 3000060230 3000062405 3000064251 3000067461 3000067855 3000071981 3000071219 3000071982 3000077342 3000080542 3000081080 3000084724 3000086852 3000087972 3000096715 3000090374 3000092556 3000097646 3000102113 3000106149 3000112151 3000114260 3000047043 3000049911 3000064746 3000067463 3000084473 3000097648 3000112153 3000047041 3000047932 3000049912 3000067856 3000071983 3000087476 3000096793 3000097649 3000112152

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 2 of 17

Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2832-2020
Recall number
Z-2832-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
16104 WW

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000047433 3000048714 3000049793 3000053296 3000054596 3000055303 3000056631 3000060227 3000064257 3000070321 3000071835 3000072581 3000072582 3000076925 3000078405 3000079518 3000080107 3000083511 3000084721 3000087689 3000092131 3000092215 3000095792 3000096364 3000097534 3000100872 3000102116 3000106750 3000107623 3000112279 3000047432 3000047933 3000049794 3000052255 3000055306 3000056632 3000061197 3000064258 3000065635 3000066086 3000066265 3000067264 3000067841 3000068601 3000068602 3000074729 3000074850 3000079519 3000081079 3000080541 3000083512 3000084722 3000087474 3000087973 3000089282 3000092129 3000092130 3000095793 3000097645 3000096762 3000097644 3000097643 3000103157 3000104738 3000106751 3000107624 3000112280 3000047434 3000047523 3000048024 3000048025 3000049795 3000052254 3000053295 3000054426 3000054425 3000055305 3000059063 3000060228 3000061341 3000064844 3000072583 3000081622 3000082248 3000082188 3000083990 3000084723 3000099218 3000104736 3000104737 3000106752 3000047309 3000047934 3000049796 3000066797 3000074731 3000083513 3000079520 3000083514 3000095794 3000096366 3000102115 3000106753 3000112278 3000047355 3000048228 3000050257 3000052253 3000054424 3000055304 3000056630 3000059062 3000060229 3000061195 3000061196 3000064259 3000064355 3000066796 3000069443 3000070319 3000080729 3000077201 3000078053 3000078919 3000080419 3000083599 3000084691 3000085499 3000086793 3000086794 3000089346 3000091874 3000090851 3000091873 3000093117 3000093118 3000093119 3000094614 3000094613 3000095319 3000095854 3000096761 3000097533 3000099217 3000100871 3000102117 3000103158 3000104739 3000106898 3000107622 3000112281 3000114254 3000071786 3000073203 3000096365 3000103156

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 3 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2833-2020
Recall number
Z-2833-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
31529 WW

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000046414 3000047431 3000048243 3000049080 3000049569 3000050495 3000051154 3000051751 3000053311 3000054591 3000054592 3000056356 3000056629 3000058277 3000060542 3000064249 3000066800 3000065563 3000067963 3000070668 3000071291 3000071979 3000073516 3000074146 3000075999 3000078921 3000080138 3000080137 3000081624 3000082197 3000082848 3000083430 3000084785 3000086995 3000087888 3000089898 3000091753 3000092239 3000092240 3000094450 3000094451 3000095604 3000096970 3000097957 3000100722 3000105063 3000102628 3000105064 3000107101 3000108962 3000109818 3000112782 3000046415 3000047430 3000048245 3000049085 3000049570 3000051153 3000051881 3000053310 3000054729 3000056538 3000059168 3000059618 3000060730 3000060451 3000064248 3000066798 3000065636 3000066799 3000067964 3000070669 3000071292 3000071980 3000073517 3000074144 3000074145 3000076000 3000078922 3000080140 3000082847 3000083431 3000083989 3000084730 3000087112 3000088376 3000089899 3000091754 3000092134 3000094449 3000095692 3000096971 3000097952 3000097953 3000100721 3000102697 3000105062 3000107100 3000109817 3000111681 3000113153 3000048244 3000049567 3000050496 3000051155 3000053312 3000054730 3000059169 3000060545 3000060543 3000066063 3000064842 3000064843 3000066801 3000066802 3000066803 3000076001 3000080543 3000080544 3000081621 3000082189 3000084786 3000086996 3000091755 3000092238 3000097956 3000102698 3000105060 3000106965 3000112155 3000112156 3000046416 3000047435 3000049568 3000056539 3000059619 3000064250 3000066804 3000066805 3000067857 3000070670 3000073518 3000074162 3000078923 3000080139 3000084731 3000097954 3000102699 3000108432 3000112154 3000103022 3000047356 3000048230 3000049055 3000051378 3000054590 3000056355 3000056628 3000059148 3000060544 3000068926 3000068941 3000073404 3000074166 3000074890 3000076131 3000076402 3000078920 3000080420 3000081777 3000083598 3000085937 3000090852 3000089347 3000091872 3000094108 3000094935 3000096067 3000095318 3000096066 3000097959 3000100857 3000100582 3000102905 3000105061 3000107102 3000108963 3000111680 3000113152 3000068029 3000071836 3000074163 3000103039 3000106964

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 4 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2834-2020
Recall number
Z-2834-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
13335 WW

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000045657 3000047164 3000048708 3000049477 3000050927 3000051753 3000051754 3000052790 3000053815 3000053816 3000056436 3000058893 3000059906 3000063263 3000064521 3000065233 3000066677 3000067689 3000071413 3000072399 3000074269 3000075922 3000077813 3000080874 3000081078 3000083096 3000084472 3000084787 3000086850 3000087366 3000088618 3000089991 3000090768 3000094337 3000097300 3000098247 3000099929 3000102977 3000106755 3000110208 3000111136 3000058894 3000070665 3000073189 3000077203 3000080875 3000084690 3000086792 3000089348 3000094338 3000103213 3000110209 3000045656 3000047710 3000048709 3000049478 3000050926 3000051752 3000052791 3000053817 3000056437 3000059907 3000061290 3000061291 3000064520 3000065234 3000065987 3000066678 3000067690 3000068924 3000069876 3000071218 3000071977 3000071978 3000073188 3000074270 3000076924 3000077812 3000080877 3000081077 3000083095 3000086851 3000087367 3000088617 3000090767 3000092537 3000094336 3000097301 3000098248 3000099928 3000102978 3000106754 3000110207 3000111137 3000046410 3000083097 3000111135 3000103214 3000110210 3000111192

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 5 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2835-2020
Recall number
Z-2835-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
32855 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000046316 3000047161 3000047162 3000048615 3000049262 3000049914 3000050929 3000051380 3000052645 3000054090 3000055099 3000056537 3000059946 3000061447 3000062406 3000065986 3000066489 3000066764 3000066770 3000068730 3000069160 3000069376 3000071293 3000071739 3000073191 3000073277 3000074271 3000075134 3000075676 3000076957 3000079650 3000081778 3000084071 3000084788 3000084789 3000086924 3000085291 3000087368 3000088278 3000088570 3000090526 3000090664 3000092443 3000096052 3000097302 3000098997 3000101522 3000103209 3000106823 3000110212 3000111023 3000112113 3000058895 3000064045 3000073190 3000077204 3000084689 3000086162 3000089349 3000094526 3000103212 3000110211 3000046315 3000047053 3000047709 3000048710 3000049479 3000050215 3000050930 3000051379 3000052646 3000054089 3000055098 3000056438 3000060258 3000060259 3000061292 3000063264 3000064522 3000066679 3000065125 3000065984 3000065985 3000066515 3000066680 3000067692 3000069161 3000069872 3000069873 3000071217 3000071891 3000073192 3000074272 3000075133 3000076154 3000076956 3000079648 3000079649 3000080226 3000081779 3000083059 3000084153 3000086058 3000087369 3000088277 3000089284 3000090665 3000092442 3000094528 3000094531 3000096053 3000096054 3000098998 3000098999 3000101523 3000103210 3000106825 3000107337 3000111022 3000112114 3000046411 3000069162 3000069442 3000071837 3000094141 3000111134 3000094151 3000094527 3000096001 3000099000 3000103211 3000106824 3000107336 3000111191 3000112115

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 6 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2836-2020
Recall number
Z-2836-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
29653 kits WW

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000102215 3000102248 3000102249 3000103405 3000103406 3000105261 3000105262 3000106963 3000107331 3000107332 3000108589 3000108881 3000110520 3000111682 3000113810 3000046748 3000102329 3000103404

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 7 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2837-2020
Recall number
Z-2837-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
69278 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000108682 3000108683 3000109819 3000110955 3000111683 3000111684 3000112929 3000112930 3000113624 3000113625 3000117020 3000046749 3000094529 3000094530 3000103206 3000104388 3000108351 3000112932

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 8 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2838-2020
Recall number
Z-2838-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
1746 kits WW

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000049797 3000053552 3000056193 3000056201 3000057749 3000066195 3000067965 3000069878 3000071222 3000072585 3000074287 3000078937 3000079446 3000080540 3000084470 3000090372 3000092553 3000095910 3000099930 3000103632 3000112148 3000053297 3000057125 3000072586 3000049798 3000053553 3000057748 3000061193 3000066264 3000069270 3000071221 3000072584 3000074288 3000077341 3000077814 3000083060 3000084471 3000087477 3000087478 3000088619 3000090373 3000092552 3000095911 3000099932 3000103631 3000053554 3000056540 3000061194 3000068728 3000092554 3000095912 3000099933 3000102246 3000049800 3000074289 3000092555 3000099931

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 9 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2839-2020
Recall number
Z-2839-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
54816 Kits WW

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000047635 3000048712 3000048711 3000049311 3000051296 3000052326 3000053634 3000054821 3000056194 3000057204 3000058417 3000059272 3000059273 3000061448 3000062934 3000065133 3000065724 3000066487 3000068135 3000069877 3000071129 3000071890 3000073519 3000074021 3000075917 3000076955 3000079930 3000077811 3000079055 3000079517 3000080673 3000082253 3000083197 3000084068 3000084852 3000084853 3000085756 3000086925 3000088673 3000089610 3000091320 3000091698 3000093895 3000096739 3000100472 3000101934 3000105734 3000106532 3000106533 3000109449 3000113519 3000116780 3000047354 3000047707 3000048027 3000048963 3000050259 3000051645 3000051646 3000052792 3000054317 3000054873 3000056073 3000057383 3000058898 3000058899 3000059609 3000061524 3000062026 3000063084 3000064055 3000066140 3000066513 3000066514 3000068859 3000070407 3000071128 3000071415 3000073402 3000074029 3000075865 3000077274 3000080105 3000077560 3000079568 3000080106 3000080444 3000080732 3000082660 3000083200 3000084477 3000085500 3000085845 3000086491 3000089458 3000090850 3000091740 3000093114 3000094658 3000095998 3000095999 3000098650 3000100381 3000102537 3000103918 3000105531 3000106633 3000109450 3000110736 3000113520 3000115115 3000048818 3000049422 3000049791 3000051295 3000053635 3000054874 3000057267 3000058418 3000058848 3000059458 3000061477 3000062027 3000065130 3000065722 3000066766 3000068923 3000070426 3000070663 3000071289 3000072588 3000072587 3000073520 3000074020 3000075914 3000076953 3000076954 3000079932 3000077810 3000079516 3000080539 3000082534 3000083198 3000084476 3000085814 3000086855 3000088103 3000089732 3000091321 3000091322 3000093116 3000094007 3000100469 3000100470 3000101888 3000101932 3000105387 3000106634 3000109452 3000048614 3000049263 3000049312 3000051297 3000051298 3000051299 3000053766 3000054338 3000054822 3000056937 3000059457 3000061523 3000065132 3000065723 3000066692 3000068136 3000068729 3000069123 3000070427 3000071290 3000071720 3000072523 3000074027 3000075916 3000075921 3000076853 3000079931 3000077809 3000079514 3000079515 3000080102 3000080731 3000083201 3000083202 3000085815 3000086856 3000086863 3000088104 3000088696 3000091478 3000091697 3000093943 3000097844 3000098672 3000101842 3000105735 3000108049 3000108048 3000113622 3000115918 3000049792 3000057344 3000058579 3000059459 3000064514 3000065131 3000066767 3000068137 3000073521 3000074028 3000083199 3000085816 3000089283 3000091479 3000094938 3000097938 3000100471 3000101844 3000109451 3000066138 3000069441 3000069655 3000071127 3000072522 3000073968 3000079897 3000080464 3000082658 3000083203 3000084566 3000086902 3000101585 3000101586 3000103054 3000107908 3000110206 3000056261 3000056262 3000061585 3000076852 3000082252 3000100001 3000100147 3000101521 3000094153 3000094937 3000103155 3000103917 3000105386 3000106635

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 10 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10

Z-2840-2020
Recall number
Z-2840-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
116652 Kits WW

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000046733 3000047274 3000047604 3000048401 3000049310 3000051066 3000051995 3000053048 3000054067 3000054914 3000057090 3000058631 3000059460 3000060261 3000060731 3000060848 3000062743 3000064057 3000071409 3000065401 3000065942 3000066768 3000067500 3000068688 3000068689 3000070070 3000072315 3000072885 3000083860 3000075682 3000076775 3000079570 3000080053 3000077520 3000077941 3000078503 3000078600 3000078656 3000079242 3000080764 3000081888 3000082186 3000082885 3000083861 3000084565 3000084851 3000085193 3000087974 3000088594 3000088639 3000089730 3000090853 3000091126 3000091327 3000092503 3000093663 3000095290 3000095946 3000096738 3000097654 3000099417 3000100344 3000101784 3000103915 3000105898 3000106317 3000109026 3000111350 3000111973 3000048959 3000047353 3000047706 3000048026 3000048961 3000048960 3000048962 3000050258 3000051647 3000052948 3000054290 3000054291 3000054967 3000056074 3000057384 3000058896 3000058897 3000060262 3000060733 3000063082 3000063083 3000064046 3000066141 3000066142 3000066284 3000067688 3000069656 3000069657 3000070408 3000070664 3000071058 3000071414 3000073065 3000073403 3000075684 3000079569 3000080103 3000077273 3000077519 3000078683 3000080104 3000080443 3000080782 3000082659 3000083600 3000085381 3000086267 3000087315 3000089459 3000090849 3000092396 3000093113 3000094005 3000095038 3000095945 3000098249 3000100378 3000102536 3000103919 3000106447 3000109023 3000110738 3000115116 3000116665 3000047198 3000047708 3000049208 3000049723 3000051122 3000052154 3000052155 3000053152 3000053792 3000054880 3000056191 3000056936 3000057345 3000058847 3000060260 3000060587 3000063258 3000064097 3000065030 3000065853 3000065943 3000066282 3000067497 3000068770 3000069317 3000070409 3000070410 3000071410 3000072886 3000072916 3000075681 3000076776 3000075131 3000079466 3000080054 3000077522 3000077523 3000077524 3000078051 3000078684 3000080537 3000080783 3000081157 3000083094 3000083092 3000083093 3000080538 3000084692 3000085501 3000085502 3000087316 3000087317 3000087975 3000088620 3000089731 3000090848 3000091184 3000091328 3000093664 3000095289 3000097650 3000099419 3000098615 3000099420 3000100266 3000101785 3000103920 3000105895 3000106449 3000106450 3000109025 3000110414 3000111358 3000111359 3000116581 3000046737 3000047275 3000047637 3000048223 3000048400 3000049421 3000049722 3000050669 3000051151 3000051152 3000052046 3000053049 3000054337 3000054915 3000057067 3000057385 3000057386 3000058630 3000060734 3000062028 3000062697 3000065235 3000065854 3000066769 3000067531 3000067532 3000067533 3000067891 3000068434 3000068731 3000069377 3000070489 3000071411 3000072230 3000072884 3000073275 3000075683 3000075675 3000075963 3000077521 3000077940 3000078502 3000078601 3000079315 3000079829 3000078934 3000080098 3000080780 3000082187 3000085290 3000087124 3000087976 3000088621 3000090854 3000091039 3000091040 3000091477 3000093115 3000095291 3000095796 3000097651 3000097652 3000098613 3000099418 3000100066 3000100346 3000101786 3000106316 3000108557 3000109401 3000110454 3000110735 3000115917 3000097096 3000046499 3000047201 3000049313 3000054879 3000056192 3000058580 3000062803 3000065029 3000065852 3000066283 3000069316 3000070488 3000072248 3000076777 3000075132 3000079467 3000079941 3000078050 3000080781 3000085503 3000088490 3000089725 3000090855 3000093675 3000097057 3000100067 3000101787 3000105897 3000109024 3000066139 3000067810 3000071126 3000072259 3000083859 3000077205 3000079828 3000082126 3000080463 3000084652 3000085504 3000087161 3000100856 3000103052 3000103053 3000107166 3000107281 3000107909 3000110205 3000046814 3000047059 3000056260 3000061584 3000076778 3000081156 3000100000 3000101129 3000101130 3000094152 3000095152 3000096000 3000097653 3000103055 3000103916 3000105384 3000106448 3000109400 3000116582 3000047356 3000048230 3000049055 3000051378 3000054590 3000056355 3000056628 3000059148 3000060544 3000068926 3000068941 3000073404 3000074166 3000074890 3000076131 3000076402 3000078920 3000080420 3000081777 3000083598 3000085937 3000090852 3000089347 3000091872 3000094108 3000094935 3000096067 3000095318 3000096066 3000097959 3000100857 3000100582 3000102905 3000105061 3000107102 3000108963 3000111680 3000113152 3000068029 3000071836 3000074163 3000103039 3000106964

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 11 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2841-2020
Recall number
Z-2841-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
2550 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000066986 3000069732 3000077731 3000077732 3000080305 3000083332 3000083333 3000084968 3000087492 3000095469 3000096180 3000096181 3000096585 3000098052 3000103498 3000104616 3000104617 3000112275 3000113067

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 12 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01

Z-2842-2020
Recall number
Z-2842-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
3059 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000051381 3000053316 3000057969 3000062074 3000066987 3000062557 3000062558 3000066988 3000064524 3000066989 3000066990 3000067890 3000069733 3000074397 3000074398 3000077670 3000077671 3000078857 3000080306 3000080310 3000083334 3000083335 3000084272 3000084969 3000087490 3000087491 3000092779 3000092780 3000095470 3000096586 3000098053 3000098054 3000098055 3000098056 3000099590 3000099591 3000112273 3000107761 3000107762 3000112274

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 13 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2843-2020
Recall number
Z-2843-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
12032 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000047804 3000053322 3000053323 3000060107 3000060108 3000062255 3000067698 3000069727 3000071976 3000073186 3000073680 3000073681 3000074885 3000076710 3000076711 3000077752 3000077753 3000079103 3000079104 3000080873 3000080872 3000081671 3000084267 3000084966 3000084965 3000086799 3000088548 3000088371 3000090599 3000090600 3000090601 3000090602 3000090603 3000092664 3000092663 3000092665 3000096263 3000095467 3000096264 3000096265 3000096266 3000098176 3000098177 3000102408 3000102409 3000103469 3000104520 3000104615 3000106012 3000107758 3000107759 3000110626 3000113155 3000112276 3000113156

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 14 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2844-2020
Recall number
Z-2844-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
11555 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000045568 3000047929 3000047928 3000047930 3000053321 3000060109 3000060110 3000067699 3000062192 3000067700 3000067701 3000069728 3000069729 3000069730 3000071288 3000073187 3000076242 3000077669 3000079105 3000079318 3000080309 3000080876 3000084268 3000084967 3000084960 3000084961 3000086800 3000088372 3000090597 3000090598 3000092668 3000092666 3000092667 3000092669 3000096268 3000095468 3000096267 3000096269 3000096270 3000096271 3000096587 3000098175 3000098747 3000098748 3000102410 3000102411 3000103470 3000104519 3000106011 3000107760 3000110622 3000110623 3000112744 3000113154

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 15 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2845-2020
Recall number
Z-2845-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
6111 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000045349 3000051218 3000053318 3000055309 3000055310 3000055311 3000056703 3000057316 3000057317 3000057967 3000066213 3000066214 3000068109 3000068110 3000068111 3000069731 3000071412 3000072401 3000072402 3000073682 3000073816 3000073817 3000074887 3000083328 3000083329 3000087746 3000076462 3000078855 3000079319 3000079320 3000083326 3000080308 3000083327 3000087747 3000090530 3000090531 3000092773 3000096367 3000096368 3000095471 3000096369 3000096370 3000096371 3000096372 3000096373 3000096374 3000098749 3000098750 3000103503 3000103504 3000103505 3000103506 3000110580 3000110581 3000110582 3000110583 3000110584 3000113008 3000113009 3000113148 3000115015

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 16 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2846-2020
Recall number
Z-2846-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
3542 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000079504 3000051211 3000051213 3000051214 3000051215 3000051216 3000051217 3000055314 3000056699 3000057319 3000057968 3000058129 3000062638 3000064726 3000068107 3000068108 3000071286 3000072715 3000072716 3000087745 3000090529 3000090660 3000092776 3000076631 3000077754 3000077755 3000080370 3000080371 3000080372 3000080373 3000080374 3000080375 3000080369 3000083330 3000084963 3000084964 3000092777 3000092778 3000095472 3000096375 3000096377 3000096378 3000098752 3000099588 3000099589

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

device · product 17 of 17

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Z-2847-2020
Recall number
Z-2847-2020
Initiated
July 27, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corporation
Quantity
3055 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential Endotoxin Contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential Endotoxin Contamination

Code information

Kit Lot Number: 3000053317 3000056694 3000057318 3000057970 3000062073 3000062639 3000062640 3000068106 3000071287 3000072717 3000064723 3000072718 3000072719 3000074886 3000087744 3000090528 3000076632 3000078856 3000080307 3000083331 3000084962 3000092774 3000092775 3000095473 3000096376 3000096606 3000096379 3000098751 3000104521 3000115011

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.