LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over
FDA device recall Z-1567-2020 · posted 2020-04-01 · Open, Classified
Recall details
- Recalling firm
- LeMaitre Vascular, Inc.
- Reason for recall
- There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
- Action taken
- 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, Inc. will send you instructions for returning the devices. 5. When the recalled devices have been received by LeMaitre Vascular, we will arrange for replacement material. 6. If you have transferred devices to another facility, please forward a copy of this recall letter to them. Customers with questions may contact the Senior Quality Engineer, at rlerer@lemaitre.com or 781-221-2266. ***Updated 8/21/20*** Firm added Lots OTW4180, OTW4187, OTW4198, OTW4202, OTW4218, OTW4246 to the recall. These lots were previously on hold in a warehouse in Germany, but in July they were mistakenly distributed to customers in Europe.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DXE
- Quantity affected
- 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, Esto
- Date initiated
- 2020-03-23
- Date posted
- 2020-04-01
- Location
- Burlington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 (K022145) | LeMaitre Vascular, Inc. | 2003-01-14 |