Sensation Plus 7 — Class II medical device recall Z-1966-2019
Terminated recall by Datascope Corporation, reported 2019-07-24, distributed in FL. The device was distributed with the outer carton labeled with the manufacture date and the expiry date reverse
| Recall number | Z-1966-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corporation, Fairfield, NJ, United States |
| Recall initiated | 2019-05-28 |
| Classified | 2019-07-12 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2023-09-25 |
| Distributed | FL |
| Countries outside the US | AT, AU, BE, CH, DE, EE, FR, GB, IE, IT, KW, LT, MX, MY, NL, PL, RU, SA, SE, SK, UA |
| Quantity | 471 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10607567108063 |
| Lot numbers | 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, 3000091828 |
| Model numbers | 0684-00-0568-01 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1966-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.