LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model… recallZ-1567-2020 · LeMaitre Vascular, Inc. · initiated Mar 23, 2020

Why it was recalled

There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.

FDA root cause category: Process control

What the company is doing

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 [email protected]. 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 [email protected] 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.

Recall details

Recall number

Z-1567-2020

Recall class

Class I (most serious)

Status

Open, Classified

Initiated by the company

Mar 23, 2020

Posted by the FDA

Apr 1, 2020

Recalling firm

LeMaitre Vascular, Inc.

Quantity

43315

Product code

DXE

FDA submissions

K022145

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, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam.

Product description

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.

Other devices under the same FDA submission

22 devices cleared under K022145 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• LeMaitre Embolectomy Catheter 1651-88

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  1 recall161 reports
• LeMaitre Embolectomy Catheter e1651-88

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  2 recalls4 reports
• LeMaitre Embolectomy Catheter 1651-44

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  1 recall38 reports
• LeMaitre Embolectomy Catheter 1651-84

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  1 recall23 reports
• LeMaitre Embolectomy Catheter 1651-38

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  1 recall19 reports
• LeMaitre Embolectomy Catheter 1651-48

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  1 recall15 reports
• LeMaitre Embolectomy Catheter e1651-84

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  1 recall14 reports
• LeMaitre Embolectomy Catheter 1651-34

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  1 recall8 reports
• LeMaitre Embolectomy Catheter 1651-78

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  1 recall4 reports
• LeMaitre Embolectomy Catheter 1651-68

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  1 recall3 reports
• LeMaitre Embolectomy Catheter e1651-38

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  1 recall1 report
• LeMaitre Embolectomy Catheter e1651-44

  Lemaitre Vascular, Inc. · Catheter, Embolectomy
  1 recall1 report