Use cautionMedical device recall · FDA · Published March 23, 2020
LeMaitre 5F Plus Catheter Recall: Risk of Tip Separation During Use
LeMaitre Vascular recalls 5F Plus Over the Wire Embolectomy Catheters with specific model numbers due to increased reports of catheters failing to deflate, which may cause tip separation during medical procedures.
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Take action
Contact the company
📍Recalling firmLeMaitre Vascular, Inc.63 2nd Ave · Burlington, MA 01803-4413
✎ GovInfoNow plain-language explainer
LeMaitre Vascular is recalling certain models of their 5F Plus Over the Wire Embolectomy Catheters because they have been reported to fail to deflate during use, potentially leading to tip separation. This could cause complications during medical procedures. Read more at govinfonow.com/recall/65607-lemaitre-5f-plus-catheter-recall-risk-of-tip-separation-during.
“LeMaitre 5F Plus Catheter Recall: Risk of Tip Separation During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65607-lemaitre-5f-plus-catheter-recall-risk-of-tip-separation-during. Based on FDA recall #Z-1567-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1567-2020%22&limit=1).
LeMaitre Vascular, Inc. recalled LeMaitre 5F Plus Over the Wire Embolectomy Catheters due to a risk of tip separation if the catheter fails to deflate, according to the FDA on March 23, 2020.
How to tell if you have it
Brand: LeMaitre
Product: LeMaitre 5F Plus Over the Wire Embolectomy Catheter
Model Nos.: 1651-84, e1651-84, 1651-88, e1651-88
The hazard
The FDA reported an increased trend in catheters failing to deflate during use, which may ultimately lead to tip separation.
Context
GovInfoNow's records show LeMaitre Vascular, Inc. has had 13 other recalls since June 19, 2018. Recent brand recalls include a TufTex Catheter recall on Aug. 28, 2026, and an Artegraft Vascular Graft recall on Feb. 10, 2026. Other recent recalls of similar products include Medtronic Harmony Catheter System Recall (May 22, 2026) and Boston Scientific Imager II Angiographic Catheters Recall (Aug. 24, 2026).
How to tell if you have this one
Check for model numbers 1651-84, e1651-84, 1651-88, e1651-88, or the OTW series numbers listed in the recall notice (e.g., OTW2897, OTW3273). The product is used in medical procedures to remove blood clots.
Brand
LeMaitre
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Model
Identify the model number on the catheter to see if it matches the recalled models listed in the recall notice.
Contact Manufacturer
Reach out to LeMaitre Vascular for guidance on whether the catheter needs to be replaced or if there are specific steps to take.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 16 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall does not require immediate discontinuation but advises checking the model number and contacting LeMaitre Vascular for guidance on next steps.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1567-2020 (March 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1567-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.