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

LeMaitre Over-the-Wire Embolectomy Catheter 6F recalled

LeMaitre Vascular is recalling LeMaitre Over-the-Wire Embolectomy Catheter 6F, 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: OTW3108¿

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-0384-2016
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: Lead & Heavy Metals
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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. 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

Is LeMaitre Over-the-Wire Embolectomy Catheter 6F recalled?

Yes. LeMaitre Vascular recalled LeMaitre Over-the-Wire Embolectomy Catheter 6F on 21 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0384-2016.

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: OTW3108¿

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

More recalls from LeMaitre Vascular

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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	Nationwide
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

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9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide