FDA Device recall Z-1687-2022
Insertion Kit for use with SENSATION PLUS 8F. 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 Insertion Kit for use with SENSATION PLUS 8F. 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-1687-2022 |
| 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
Insertion Kit for use with SENSATION PLUS 8F. 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.": 10607567108599, 3000170709, 0884-00-0019-23; 1060756…Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567108599, 3000170709, 0884-00-0019-23; 10607567108599, 3000182611, 0884-00-0019-23; 10607567108599, 3000202083, 0884-00-0019-23 |
|---|
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-1687-2022%22
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