Recall Z-1454-2014— Micro Therapeutics Inc, Dba Ev3 Neurovascular

Name: FDA recall Z-1454-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-01

Class I · Terminated

Class I FDA medical device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, initiated 2014-04-01, terminated 2014-10-31. It names one FDA 510(k) clearance: K043580. Product: Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.. Reason: Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire..

Recalling firm: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Classification: Class I
Status: Terminated
Initiated: 2014-04-01
Terminated: 2014-10-31
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K043580 — ALLIGATOR RETRIEVAL DEVICE (ARD)Chestnut Medical Technologies, Inc.·cleared 2005-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.

Reason for recall

Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

Data sourced from openFDA. This site is unofficial and independent of the FDA.