RecallRadar

FDA Device recall Z-0308-2017

Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal

On 2016-11-16 the FDA classified a Class I recall of Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal by Micro Therapeutics, citing delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0308-2017
ClassificationClass I
Statusterminated
Initiated2016-10-05
Published2016-11-16
Last updated2026-09-13 11:54 UTC
CompanyMicro Therapeutics
DistributionUS

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

Reason

Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.

Identifiers

code_info
9948077 9972887 A010848 A053541 A116064 A131036 9948396 9972889 A011322 A053542 A117476 A132044 9952512 99…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 A

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0308-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.