Recall Z-1686-2022— Datascope Corporation
Class II · Ongoing
Class II FDA medical device recall by Datascope Corporation, initiated 2022-08-05. It names one FDA 510(k) clearance: K133074. Product: Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter. Reason: Certain lots containing undersized dilator..
- Recalling firm
- Datascope Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-05
- Firm location
- Fairfield, NJ, United States
510(k) clearances named in this recall
1 on FDA's record- K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Reason for recall
Certain lots containing undersized dilator.
Data sourced from openFDA. This site is unofficial and independent of the FDA.