TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserte
Summary
The FDA issued a Class II for TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and by LeMaitre Vascular, Inc.. Reason: Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could.
Details
Source
Device Recall
External ID
Z-0228-2023
Action Date
2022-11-23
Status
Ongoing
Category
device
Product Description
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/Code Info: Lots XSL0097, XSL0098, and XSL0099
Quantity Affected: 72 (OUS only)
Reason for Recall
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.
Distribution
No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-30
Company
Burlington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LeMaitre Vascular, Inc. has 11 FDA actions in our database, including 10 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LeMaitre Vascular, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LeMaitre Vascular, Inc. have FDA actions?
LeMaitre Vascular, Inc. has 11 FDA actions in our database, including 10 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0228-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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