Recall Z-2837-2020 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
| Date | Aug 21, 2020 (initiated Jul 27, 2020) |
| Status | Open, Classified |
| Reason | Potential Endotoxin Contamination |
| Root cause | Process change control |
| Action | Datascope/Getinge issued Urgent Medical Device Removal letter (customer specific) on 7/27/20, via FedEx with Signature Proof of Delivery. Letter states reason for recall, health risk and action to take: Records indicate that you received potentially affected IABs identifiable by the lot and serial numbers listed . Please complete the steps below: Monitor patients for pyrogens reaction/humoral immune response/ coagulation and complement cascades/ inflammation. Monitor and treat any signs of inflammation according to your facilitys protocols and clinical judgment. Please examine your invento |
| Quantity | 69278 kits |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, S |
| 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 |