Recall Z-1685-2022 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corporation
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
| Date | Sep 8, 2022 (initiated Aug 5, 2022) |
| Status | Open, Classified |
| Reason | Certain lots containing undersized dilator. |
| Root cause | Vendor change control |
| Action | The firm distributed an Urgent Medical Device Removal notification, by mail, dated August 5, 2022. The notification informs customers that certain lots of 8Fr. 50cc IAB catheter and insertion kits are being recalled due to an undersized vessel dilator. During a sheathless insertion, the undersized inner diameter may result in the inability to insert the guidewire through the inner lumen of the dilator and the undersized outer diameter may reduce dilation of the vessel. If used in a procedure, recalled product could result in a procedural delay, gas emoli, and vessel injury. Customers are ask |
| Quantity | 10,427 units |
| Distribution | Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES Datascope Corp., Dec 12, 2013 |