LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed adverse events.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 4,315 units of the LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. The recall affects lot codes OTW3094 and OTW3098. The product is indicated for the removal of arterial emboli and thrombi.
The recall was initiated due to a manufacturing issue that could cause a pinhole in the formed end of the packaging. This defect may lead to compromised sterility of the medical device.
The affected devices were distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations such as Australia, Austria, Belgium, and the United Kingdom. Healthcare providers and facilities should check their inventory for the specific model numbers and lot codes listed and stop using the affected devices.
The recalled product
- Product
- LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 4,315
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 (1)
- Lot Codes: OTW3094¿and OTW3098¿
Distribution
Part of a larger recall action
This product is one of 13 recalled by LeMaitre Vascular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · LeMaitre Vascular, Inc.
See all →- 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
- SevereTufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier
FDA (Devices) · 2025-05-21
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12