Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0380-2016 — LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.

U.S. FDA — Device Enforcement · United States · 2015-10-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0380-2016
Date of alert
2015-10-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
LeMaitre Vascular, Inc.
Product category
device
Product type
Devices
Reported risk: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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