LeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
LeMaitre Vascular, Inc. is recalling 54 TufTex Over-the-Wire Embolectomy Catheters because the balloon components may fail under pull force.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II, and the source describes a mechanical failure in the balloon components during process testing. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 54 units of the TufTex Over-the-Wire Embolectomy Catheter, Catalog Number E1651-88. The recall is due to a failure in process testing related to the amount of pull force the balloon components can sustain before failing.
The affected devices were distributed nationwide in the states of California, Florida, Georgia, Kentucky, Louisiana, New Jersey, Ohio, Pennsylvania, and South Carolina. The specific lot number is XOT00002181, and the UDI-DI is 00840663100866.
Healthcare providers and facilities should stop using the affected devices and contact LeMaitre Vascular, Inc. for instructions on return or replacement. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
- Manufacturer
- LeMaitre Vascular, Inc.
- Hazard
- Affected units
- 54
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)
- Catalog Number: E1651-88
- UDI-DI: 00840663100866
- Lot Number: XOT00002181
Distribution
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