FDA Device recall Z-1685-2022
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
- FDA Device
- Class II
- ongoing
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of MEGA 8Fr 50cc Intra-Aortic Balloon Catheter by Datascope, citing certain lots containing undersized dilator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1685-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-05 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Datascope |
| Distribution | n/a |
Product
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Reason
Certain lots containing undersized dilator.
Identifiers
| code_info | Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567109619, 3000184437, 0684-00-0296-01U; 106075…Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567109619, 3000184437, 0684-00-0296-01U; 10607567107301, 3000171501, 0684-00-0498-01; 10607567107301, 3000183312, 0684-00-0498-01; 10607567107301, 3000183313, 0684-00-0498-01; 10607567107301, 3000186654, 0684-00-0498-01; 10607567107301, 3000186655, 0684-00-0498-01. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1685-2022%22
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