FDA Recalls Alligator Retrieval Devices Due to Coating Delamination Risk
Micro Therapeutics Inc is recalling Alligator Retrieval Devices because the PTFE coating may delaminate and detach from the delivery wire.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling the Alligator Retrieval Device (ARD) under FDA recall number Z-1454-2014. The ARD is a medical device used in the peripheral and neurovasculature for foreign body removal. The recall is due to a potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
A total of 567 units are affected, with 323 units distributed in the United States, including Puerto Rico. The remaining units were distributed worldwide to Australia, Germany, France, the UK, Turkey, Argentina, Canada, Colombia, Mexico, Austria, Belgium, Denmark, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and the UAE. Specific model and lot numbers are listed in the agency's official recall record.
This is classified as an FDA Class I recall, which indicates a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death. Healthcare providers and patients should contact the manufacturer or their local FDA office for further instructions on how to proceed with the recall.
The recalled product
- Product
- Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Neurovascular
Distribution
Part of a larger recall action
This product is one of 2 recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular 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.
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