Recall Z-0131-2023 ยท DSQ Ventricular (Assist) Bypass
Datascope Corporation
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
| Date | Oct 24, 2022 (initiated Aug 5, 2022) |
| Status | Open, Classified |
| Reason | The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable. |
| Root cause | Labeling Change Control |
| Action | On August 5, 2022, the firm notified affected customers via Urgent Field Safety Notice Medical Device Removal letters. Customers were instructed to examine their inventory for the affected product. Customers may return the product for full credit. The firm also informed customers that given current supply chain shortages that they are unable to commit to a timely replacement of affected catheters. |
| Quantity | 4414 OUS |
| Distribution | No US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Pakistan, Poland, Portugal, South Korea, Russia, Spain, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay. |
| 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 |