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U.S. Department of Health and Human Services

Class 1 Device Recall Pipeline Flex Embolization Device

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  Class 1 Device Recall Pipeline Flex Embolization Device see related information
Date Initiated by Firm February 14, 2020
Date Posted March 09, 2020
Recall Status1 Terminated 3 on June 12, 2024
Recall Number Z-1527-2020
Recall Event ID 85069
PMA Number P100018 
Product Classification Intracranial aneurysm flow diverter - Product Code OUT
Product ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Code Information Lots: A920066 A920068 A920069 A920070 A920071 A920072 A920073 A920074 A920075 A920076 A920078 A920079 A921354 A921355 A921356 A921357 A921358 A921359 A921360 A921361 A921362 A921363 A922016 A922017 A922018 A922020 A922021 A922022 A922480 A922481 A922483 A922484 A922571 A922572 A922575 A923951 A923956 A923959 A923960 A923963 A923967 A923968 A923969 A924193 A924194 A924197 A924198 A924199 A924638 A924640 A924641 A924642 A924643 A924644 A924645 A924646 A924647 A924648 A924650 A927827 A927828 A927829 A927830 A927831 A927832 A927833 A927834 A927835 A927836 A927837 A927838 A927839 A927840 A927841 A927842 A927843 A927844 A927845 A927847 A927848 A929704 A929705 A929706 A929707 A929708 A929710 A929711 A929713 A929714 A929716 A929717 A929893 A929894 A929896 A929897 A929898 A929901 A929902 A929903 A929904 A929906 A929907 A932604 A932605 A932607 A932609 A932610 A932611 A932612 A932613 A933706 A933707 A933709 A933710 A933781 A933782 A933783 A933784 A933785 A933786 A933787 A933788 A933789 A934499 A934500 A934503 A934504 A934505 A934506 A935182 A935184 A937237 A937238 A937239 A937240 A937241 A937645 A937646 A937647 A937648 A937649 A937650 A937651 A937652 A937653 A937654 A938289 A938290 A938291 A938293 A939611 A941306 A941307 A941308 A941309 A941310 A942157 A942159 A942160 A942161 A942162 A942163 A942164 A942165 A942166 A944241 A944242 A944244 A944245 A944246 A944247 A944249 A944250 A944251 A944253 A944254 A944255 A944256 A944257 A945204 A945205 A945438 A945441 A945445 A945447 A945450 A945451 A945452 A945454 A945455 A946808 A946811 A946813 A946815 A946816 A946817 A947150 A947151 A947152 A947153 A947154 A947155 A947396 A947397 A947398 A947399 A947400 A947401 A947402 A947403 A947405 A947407 A947408 A948123 A948124 A948125 A948126 A948127 A948128 A948129 A948130 A948131 A949486 A949487 A949488 A949489 A949490 A949491 A949492 A949493 A949494 A949495 A949496 A949497 A950324 A950329 A950332 A950333 A950335 A950337 A950341 A950344 A950346 A950753 A950754 A950945 A950946 A950947 A952499 A952500 A953289 A953290 A953291 A953292 A953294 A953295 A953296 A953297 A955938 A955939 A955940 A955943 A955944 A955945 A955946 A955947 A955948 A956502 A956504 A956505 A956506 A956507 A956508 A956509 A956510 A956511 A956512 A957173 A957175 A957176 A957270 A957271 A957272 A957273 A957274 A957282 A957461 A957470 A957472 A957473 A957475 A957476 A957477 A957478 A957479 A957480 A957481 A957483 A957484 A957485 A957486 A957488 A957490 A957492 A958533 A958534 A958535 A958536 A958537 A958538 A958539 A958540 A958542 A958543 A958547 A959339 A959341 
Recalling Firm/
Micro Therapeutics Inc, Dba Ev3 Neurovascular
9775 Toledo Way
Irvine CA 92618-1811
Manufacturer Reason
for Recall
Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
FDA Determined
Cause 2
Process change control
Action On 02/14/20, Medtronic mailed Urgent Medical Device Recall notices to Healthcare Professionals and Risk Managers. They were advised of the following: 1) Do not use any affected product. Remove and quarantine all unused affected products in your inventory. 2) Return the affected products. Medtronic representatives can assist with facilitating the return of affected product and with identifying suitable replacement product. 3) Complete and return the Customer Confirmation Form. In addition, customers were asked to share the communication within their organization, with other organizations where affected devices were transferred, and any other associated organizations that may be impacted. On 09/04/2020, a Safety and Labeling Notification was sent to customers informing them that that Instructions for Use will be supplemented to update the Precaution and Warning statements and the Device Complications section. Medtronic recommends that physician users be attentive to the updated information in the Instructions for Use and include this information in discussions with patients. Further, please share this communication within your organization, with other organizations where these devices have been transferred, and any other associated organizations that may be impacted by this action.
Quantity in Commerce 1050
Distribution Worldwide distribution. US nationwide, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Kazakhstan, Korea, Lebanon, Mexico, Netherlands, Norway, Paraguay, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam
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.
PMA Database PMAs with Product Code = OUT and Original Applicant = Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR