Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign…
Medical device recall Z-0308-2017. Published in FDA’s Enforcement Report on Nov 16, 2016.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 16, 2016. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3,337 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
3,337 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
9948077 9972887 A010848 A053541 A116064 A131036 9948396 9972889 A011322 A053542 A117476 A132044 9952512 9972890 A011359 A053543 A118368 A154323 9957329 9974418 A013554 A053763 A120498 A154324 9957336 9976051 A013556 A053764 A122265 A156580…
Every code shown here, 1,511 characters
9948077 9972887 A010848 A053541 A116064 A131036 9948396 9972889 A011322 A053542 A117476 A132044 9952512 9972890 A011359 A053543 A118368 A154323 9957329 9974418 A013554 A053763 A120498 A154324 9957336 9976051 A013556 A053764 A122265 A156580 9957342 9976060 A014832 A053766 A123213 A156581 9944965 9977018 A014868 A066445 A124445 A161317 9945280 9977019 A014953 A066446 A125283 A161318 9951876 9977396 A016804 A068660 A132937 A163895 9954273 9977397 A018473 A068664 A134257 A163896 9957330 9978556 A019068 A071295 A134900 A166199 9957339 9978557 A021485 A072578 A135945 A168759 9957343 9979590 A022023 A091991 A137794 A168760 9957347 9980261 A022527 A093697 A138489 A173721 9945281 9980272 A024541 A094487 A142716 A173722 9946234 A002055 A026133 A095510 A147975 A177071 9952511 A002875 A027036 A096506 A147976 A177073 9957331 A002976 A028730 A098665 A147978 A197692 9957340 A004046 A028731 A098667 A150526 A242153 9957344 A004049 A030919 A102229 A150527 A242931 9948387 A005156 A030920 A102232 A150529 A242936 9950866 A006168 A033160 A104111 A152100 A242937 9953649 A006169 A033161 A104113 A153748 A242939 9954974 A007336 A036879 A107473 A153749 A247199 9955940 A007955 A037969 A110323 A127224 A247612 9957333 A008188 A039135 A111254 A127844 A254814 9957341 A009329 A039136 A112093 A129002 A282350 9957346 A010342 A039142 A114200 A130573 A290956 A311410 A312892 A321463 Additional Lots 9973587 A003969 A003985 A004024 A004819 A004964 A004983 A005025 A005630 A005730 A006093 A006966 A007043 A008142 A008144 A011434
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US (nationwide) and Internationally to 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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 5, 2016.
- FDA classified it on Nov 9, 2016.
- FDA’s Enforcement Report published it on Nov 16, 2016.
- FDA terminated it on Oct 11, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Micro Therapeutics Inc, Dba Ev3 Neurovascular, of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.