CLASS II Device recall · Reported 16 Dec 2015 · FDA Enforcement Report

LeMaitre Single Lumen Embolectomy Catheter 3F recalled

LeMaitre Vascular is recalling LeMaitre Single Lumen Embolectomy Catheter 3F, distributed nationwide in the US. The recall was initiated on 21 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: SLC3672¿SLC3663 SLC3663¿SLC3667¿

Quantity recalled4315 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0386-2016
FDA event ID: 72534
Recalling firm: LeMaitre Vascular, Burlington, MA
Classification: Class II
Status: Terminated
Recall initiated: 21 Oct 2015
FDA classified: 4 Dec 2015
Reported: 16 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

21 Oct 2015	Recall initiated by company
4 Dec 2015	Classified by FDA	+44 days
16 Dec 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.

Where it was distributed

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Which lots are affected?

Lot Number: SLC3672¿SLC3663 SLC3663¿SLC3667¿

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

12 other products · FDA event 72534

This product is part of a recall event; the main page for the event is LeMaitre Over-the-Wire Embolectomy Catheter 6F recalled.

Reported	Class	Recall	Company	Reason	Where
16 Dec 2015	CLASS II	LeMaitre Over-the-Wire Embolectomy Catheter 6F recalled	LeMaitre Vascular	Sterility	Nationwide
16 Dec 2015	CLASS II	LeMaitre Over-the-Wire Embolectomy Catheter 3F recalled	LeMaitre Vascular	Sterility	Nationwide
16 Dec 2015	CLASS II	LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F recalled	LeMaitre Vascular	Sterility	Nationwide
16 Dec 2015	CLASS II	LeMaitre Single Lumen Embolectomy Catheter 4F recalled	LeMaitre Vascular	Sterility	Nationwide
16 Dec 2015	CLASS II	LeMaitre Over-the-Wire Embolectomy Catheter 4F recalled	LeMaitre Vascular	Sterility	Nationwide
16 Dec 2015	CLASS II	LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F recalled	LeMaitre Vascular	Sterility	Nationwide
16 Dec 2015	CLASS II	LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus recalled	LeMaitre Vascular	Sterility	Nationwide
16 Dec 2015	CLASS II	LeMaitre Over-the-Wire Embolectomy Catheter 6F recalled	LeMaitre Vascular	Sterility	Nationwide
16 Dec 2015	CLASS II	LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus recalled	LeMaitre Vascular	Sterility	Nationwide
16 Dec 2015	CLASS II	LeMaitre Single Lumen Embolectomy Catheter 5F recalled	LeMaitre Vascular	Sterility	Nationwide
16 Dec 2015	CLASS II	LeMaitre Over-the-Wire Embolectomy Catheter 7F recalled	LeMaitre Vascular	Sterility	Nationwide
16 Dec 2015	CLASS II	LeMaitre Over-the-Wire Embolectomy Catheter 3F recalled	LeMaitre Vascular	Sterility	Nationwide

More recalls from LeMaitre Vascular

All 70

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS II	Artegraft Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Packaging Defects	Nationwide
29 Oct 2025Device	CLASS II	Artegraft¿ Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Packaging Defects	AR
15 Oct 2025Device	CLASS II	Artegraft Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Labeling Errors	NJ
8 Oct 2025Device	CLASS II	Artegraft Collagen Vascular Grafts recalled by LeMaitre Vascular	LeMaitre Vascular	Other	Nationwide
21 May 2025Device	CLASS II	Pruitt Irrigation Occlusion Catheter recalled by LeMaitre Vascular	LeMaitre Vascular	Sterility	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide