LeMaitre Stent Guide Recalled Due to Compromised Sterility
LeMaitre Vascular, Inc. is recalling LeMaitre Stent Guide strips because they were not sealed correctly during manufacturing, compromising their sterility.
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: The recall is classified as FDA Class II. The hazard involves compromised sterility of a medical device, which poses a risk of infection, but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
LeMaitre Vascular, Inc. is recalling LeMaitre Stent Guide strips (catalog numbers 1102-00, 1102-50, and 1102-20) due to a manufacturing defect. The devices were not sealed correctly during the production process, which has compromised the sterility of the products.
The recalled units are intended to be placed on the skin to assist during imaging procedures. The recall affects 6,970 units distributed nationwide in the United States, as well as in Canada, the European Union, and Asia. Specific lot codes LSG1130 (expiration 2017-04) and LSG1132 (expiration 2017-11) are identified in the recall notice.
The U.S. Food and Drug Administration has classified this as a Class II recall. Healthcare providers and facilities should stop using these devices and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
- Manufacturer
- LeMaitre Vascular, Inc.
- Affected units
- 6,970
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 (4)
- LSG1130
- exp. 2017-04
- LSG1132
- exp. 2017-11
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by LeMaitre Vascular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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