LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk
LeMaitre Vascular is recalling 4,315 embolectomy catheters worldwide due to a manufacturing defect that may compromise packaging 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 and involves a risk of compromised sterility in a medical device, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 4,315 units of the LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm (Model 1601-58 and e1601-58). The recall covers lots SLC3673 through SLC3637, SLC3637 through SLC3666, and SLC3676 through SLC3689. The product is indicated for the removal of arterial emboli and thrombi.
The recall was initiated due to a manufacturing issue that could cause a pinhole in the formed end of the packaging. This defect may lead to compromised sterility of the medical device. The FDA has classified this recall as Class II.
The affected products were distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations such as Australia, Austria, Belgium, Colombia, Costa Rica, Czech Republic, Denmark, Egypt, France, Germany, Iceland, Italy, Japan, Jordan, Latvia, Luxembourg, Morocco, Netherlands, Norway, Oman, Peru, Portugal, Poland, Slovenia, Spain, Switzerland, Sweden, Thailand, United Kingdom, United Arab Emirates, and Vietnam. Users should stop using the affected devices and contact the manufacturer for instructions.
The recalled product
- Product
- LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 4,315
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 (1)
- Lot Number: SLC3673¿SLC3637 SLC3637¿SLC3666 SLC3676¿SLC3689¿
Distribution
Part of a larger recall action
This product is one of 13 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.
See all 13 products in this recall →Related recalls
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