FDA Device recall Z-2835-2020
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-…
- FDA Device
- Class II
- ongoing
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class II recall of 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-… by Datascope, citing potential Endotoxin Contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2835-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-07-27 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Datascope |
| Distribution | US |
Product
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.
Reason
Potential Endotoxin Contamination
Identifiers
| code_info | Kit Lot Number: 3000046316 3000047161 3000047162 3000048615 3000049262 3000049914 3000050929 3000051380 30000…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2835-2020%22
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