Ev3 Neurovascular Alligator Retrieval Device Recalled for Coating Defect
Micro Therapeutics Inc. is recalling 3,337 Alligator Retrieval Devices because the PTFE coating may delaminate and detach, potentially entering the bloodstream.
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 agency classified this recall as FDA Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Micro Therapeutics Inc., d/b/a Ev3 Neurovascular, is recalling 3,337 units of the Alligator Retrieval Device. The device is intended for use in the peripheral and neurovasculature for foreign body removal. The recall covers specific catalog numbers including FA-88810-20V04, FA-88810-20V06, FA-88810-30V04, FA-88810-30V06, FA-88810-40V04, FA-88810-40V06, FA-88810-50V04, and FA-88810-50V06.
The recall was initiated because delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating entering the bloodstream. The agency has classified this recall as Class I.
The affected devices were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
The recalled product
- Product
- Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Neurovascular
- Affected units
- 3,337
Distribution
Part of a larger recall action
This product is one of 4 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Micro Therapeutics Inc, Dba Ev3 Neurovascular
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Same hazard · coating detachment
See all →- SevereEv3 Neurovascular Recalls Marathon and UltraFlow Micro Catheters
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