FDA Device recall Z-1966-2019
Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.…
- FDA Device
- Class II
- terminated
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class II recall of Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.… by Datascope, citing the device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1966-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-28 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Datascope |
| Distribution | FL |
Product
Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Reason
The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
Identifiers
| code_info | UDI Code: 10607567108063; Lot Codes: 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, 3000091828 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1966-2019%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.