Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Reported: April 23, 2014 Initiated: April 1, 2014 #Z-1454-2014
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.
Details
- Recalling Firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Units Affected
- 567 units total (323 units in US)
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.. Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular. Units affected: 567 units total (323 units in US).
Why was this product recalled? ▼
Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2014. Severity: Critical. Recall number: Z-1454-2014.
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