LeMaitre Embolectomy Catheter Recall for Deflation Failure and Tip Separation
LeMaitre Vascular is recalling 5F Plus Over the Wire Embolectomy Catheters due to reports of deflation failure that may lead to tip separation.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect (tip separation) in a medical device used for invasive procedures, which aligns with the rubric criteria for 'structural vehicle defect' or 'significant injury/property-damage reports' by analogy to high-risk mechanical failures in medical devices.
Plain-English summary
LeMaitre Vascular, Inc. is recalling the LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, and e1651-88. The recall involves 43,315 units distributed worldwide, including the United States and numerous foreign countries.
The recall is being conducted because of an increased trend in reports of the catheters failing to deflate during use. This failure may ultimately lead to tip separation. The catheter is indicated for the removal of emboli and thrombi during embolectomy and/or thrombectomy, as well as for catheter placement over a guidewire, vessel occlusion, fluid infusion, and aspiration.
Healthcare providers and facilities should stop using the affected devices and contact LeMaitre Vascular for instructions on return or replacement. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- 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…
- Manufacturer
- LeMaitre Vascular, Inc.
- Affected units
- 43,315
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- OTW4187
- OTW4198
- OTW4202
- OTW4218
- OTW4246
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · LeMaitre Vascular, Inc.
See all →- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- ModerateArtegraft vascular graft recalled over incorrect lot outer packaging labeling
FDA (Devices) · 2026-03-25
- ModerateCollagen vascular graft recalled after being packed in wrong size packaging
FDA (Devices) · 2025-10-29
- ModerateCollagen vascular grafts recalled over incorrect labels missing CE and UKCA marks
FDA (Devices) · 2025-10-15
- ModerateCollagen vascular grafts recalled over unapproved bovine raw material supplier
FDA (Devices) · 2025-10-08
Same hazard · tip separation
See all →- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- SevereCook Beacon Tip Angiographic Catheters Recalled for Tip Separation Risk
FDA (Devices) · 2025-06-25
- SevereRoute 92 Medical delivery catheter recalled due to tip separation risk
FDA (Devices) · 2024-05-01
- SevereRoute 92 Medical Access System Recalled for Distal Tip Separation
FDA (Devices) · 2024-05-01
Similar recalls
- ModerateLeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk
FDA (Devices) · 2015-12-16
- ModerateLeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect
FDA (Devices) · 2015-12-16
- HighLeMaitre Over-the-Wire Embolectomy Catheter Recall for Packaging Defect
FDA (Devices) · 2015-12-16
- HighLeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk
FDA (Devices) · 2015-12-16
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- SevereTufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier
FDA (Devices) · 2025-05-21