FDA Device recall Z-2839-2020
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-…
- 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 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-… by Datascope, citing potential Endotoxin Contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2839-2020 |
| 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 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.
Reason
Potential Endotoxin Contamination
Identifiers
| code_info | Kit Lot Number: 3000047635 3000048712 3000048711 3000049311 3000051296 3000052326 3000053634 3000054821 30000…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 |
|---|
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-2839-2020%22
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