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Datascope Corporation FDA Recalls
4 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Sensation Plus 8Fr 50cc Intra-Aortic Balloon CatheterClass IIAug 5, 2022Certain lots containing undersized dilator. |
| LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.Class IIAug 5, 2022The balloon volume is incorrectly described as 34cc instead |
| Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon CatheterClass IIAug 5, 2022Certain lots containing undersized dilator. |
| MEGA 8Fr 50cc Intra-Aortic Balloon CatheterClass IIAug 5, 2022Certain lots containing undersized dilator. |