Reported Nov 23, 2022 · Ongoing
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted…
LeMaitre Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LeMaitre Vascular, Inc. · 32 3rd Ave · Burlington, MA · 01803-4414
Is this the product you have?
- TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
- Lot codes and dates
Lots XSL0097XSL0098and XSL0099
- Amount recalled
- 72 (OUS only)
Why it was recalled
Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.
This product could cause temporary or reversible health problems — stop using it.
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