FDA Device recall Z-2840-2020
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-…
- 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)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-… by Datascope, citing potential Endotoxin Contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2840-2020 |
| 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)-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
Reason
Potential Endotoxin Contamination
Identifiers
| code_info | Kit Lot Number: 3000046733 3000047274 3000047604 3000048401 3000049310 3000051066 3000051995 3000053048 30000…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 |
|---|
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-2840-2020%22
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