Class 1 Device Recall Alligator Retrieval Device

• Date Initiated by Firm: October 05, 2016
• Date Posted: November 09, 2016
• Recall Status: Terminated on October 11, 2017
• Recall Number: Z-0308-2017
• Recall Event ID: 75358
• PMA Number: P100018
• Product Classification: Catheter, percutaneous - Product Code DQY
• 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Micro Therapeutics Inc, Dba Ev3 Neurovascular; 9775 Toledo Way; Irvine CA 92618-1811
• For Additional Information Contact: 949-837-3700
• Manufacturer Reason for Recall: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
• FDA Determined Cause: Device Design
• Action: Medtronic sent an Urgent Medical Device Recall letter dated October 5, 2016, to all affected customers to inform them that Medtronic has identified the potential for an issue with a specific set of lot numbers of Medtronic Neurovascular products as noted where the PTFE (polytetrafluoroethylene) coating could delaminate and separate from the delivery wire. Customers are instructed to complete the attached customer confirmation certificate and fax it to Medtronic at (949) 434-5020 to the attention of Neurovascular Quality. On October 14, 2016, Medtronic announced that it has notified customers of a voluntary recall of certain lots of its Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters. This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event. Customers were asked to complete the attached Customer Confirmation Certificate and fax it to Medtronic at 1-949-434-5020 to the attention of Neurovascular Quality. Customers with questions were instructed to contact their Medtronic representative. On 1/12/17, an Urgent Medical Device Recall letter was sent to expand the recall to include additional lots.
• Quantity in Commerce: 3,337 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.