Recall Z-1567-2020 ยท DXE Catheter, Embolectomy
LeMaitre Vascular, Inc.
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
| Date | Apr 1, 2020 (initiated Mar 23, 2020) |
| Status | Open, Classified |
| Reason | There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. |
| Root cause | Process control |
| Action | On March 23, 2020, the firm distributed "URGENT: MEDICAL DEVICE RECALL" letters to affected customers. Customers were notified of the risk of the catheter failing to deflate, which may ultimately lead to tip separation. Customers were asked to do the following: 1. Check your inventory and immediately quarantine any recalled devices. 2. Complete the form at the end of this letter. Please note that you must return the form even if you have no devices in inventory. 3. Scan the reply form and send it to recalls@lemaitre.com. 4. If you have recalled devices at your facility, LeMaitre Vascular, In |
| Quantity | 43315 |
| Distribution | Worldwide distribution: US (Nationwide distribution) and foreign countries of: Australia, Austria, Belgium, Bulgaria, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Georgia, Hungary, Ireland, Israel, Italy, Japan, Korea, Netherlands, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022145 | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 LeMaitre Vascular, Inc., Jan 14, 2003 |