Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
FDA device recall Z-1824-2024 · posted 2024-05-15 · Open, Classified
Recall details
- Recalling firm
- LeMaitre Vascular, Inc.
- Reason for recall
- The guide tip can become damaged and result in the tip detaching.
- Action taken
- Consignees were mailed an URGENT MEDICAL DEVICE RECALL Notification, dated 4/10/2024. The notification instructs consignees to inspect their inventory for and quarantine affected devices, complete and return the provided Response Form to recalls@lamaitre.com, and return affected devices for credit. If product was further distributed, the recall notification is to be forwarded for customer awareness. Consignees with any questions are to contact Rose Lerer at rlerer@lemaitre.com from Monday through Friday, 8:00 AM to 4:30 PM EST.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DXE
- Quantity affected
- 5,604 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.
- Date initiated
- 2024-04-17
- Date posted
- 2024-05-15
- Location
- Burlington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTIMAX THROMBECTOMY CATHETER (K910372) | Applied Vascular Devices, Inc. | 1991-04-26 |