LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
FDA device recall Z-0131-2023 · posted 2022-10-24 · Open, Classified
Recall details
- Recalling firm
- Datascope Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- DSQ
- Quantity affected
- 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
- Date initiated
- 2022-08-05
- Date posted
- 2022-10-24
- Location
- Fairfield, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES (K041281) | Datascope Corp. | 2004-06-07 |