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

Recall Z-1489-2014 — ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter

U.S. FDA — Device Enforcement · United States · 2014-04-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1489-2014
Date of alert
2014-04-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ev3, Inc.
Product category
device
Product type
Devices
Reported risk: Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling.
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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