FDA Device recall Z-2845-2020
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications F…
- 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)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications F… by Datascope, citing potential Endotoxin Contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2845-2020 |
| 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)-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.
Reason
Potential Endotoxin Contamination
Identifiers
| code_info | Kit Lot Number: 3000045349 3000051218 3000053318 3000055309 3000055310 3000055311 3000056703 3000057316 30000…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 |
|---|
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-2845-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.