Recall Z-0311-2025 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
| Date | Nov 5, 2024 (initiated Sep 17, 2024) |
| Status | Open, Classified |
| Reason | There is discrepant labeling on the inner and outer packaging of the device. |
| Root cause | Error in labeling |
| Action | An URGENT MEDICAL DEVICE REMOVAL notification letter was sent to customers beginning 9/23/24. Actions to be taken by the user: Our records indicate that you have received one or more of the affected MEGA 7.5Fr 40cc IAB devices. Please examine your inventory immediately to determine if you have any impacted product. See pictures of the outer cartons for the potentially impacted product below. Please verify all labels, IFU, and IAB against the artwork on the outer carton. If the product, IFU, and labels all match the information for the MEGA 7.5Fr 40cc outer carton (circled green in the seco |
| Quantity | 160 units |
| Distribution | International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041281 | DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES Datascope Corp., Jun 7, 2004 |
| K112327 | SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES Cardiac Assist, Maquet Cardiovascular, LLC, Sep 9, 2011 |
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES Datascope Corp., Dec 12, 2013 |