TufTex Embolectomy Catheter Recalled for Inadequate Ligature Ties
LeMaitre Vascular recalled three lots of TufTex Embolectomy Catheters with inadequate ligature ties. The defect risks the catheter tip breaking off and becoming lodged in a blood vessel.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II medical device recall involving a manufacturing defect (inadequate ligature ties) that creates risk of device fracture and potential foreign body embolism in blood vessels. No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products with no reported injury score 3 (High).
Plain-English summary
LeMaitre Vascular, Inc. is recalling three lots of TufTex Embolectomy Catheters (Models 3F and 4F) due to inadequate ligature ties. The affected lots are XSL0097, XSL0098, and XSL0099. These devices were tied by two trainees without performing the required pull test, allowing them to be released with defective ligatures.
The catheters contain a latex balloon and single lumen. If the proximal ligature is inadequately tied, it could slip toward the catheter tip and block the inflation hole. This could lead to the catheter tip breaking off and becoming lost in the patient's blood vessel.
This recall affects 72 units distributed outside the United States to the United Kingdom, Germany, France, Sweden, Austria, and Italy. No incidents or injuries have been reported to date. The FDA classified this as a Class II recall.
The recalled product
- Product
- 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..
- Manufacturer
- LeMaitre Vascular, Inc.
- Affected units
- 72
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 (3)
- Lots XSL0097
- XSL0098
- and XSL0099
Distribution
Distribution scope not specified by the agency.
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