ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

FDA device recall Z-1528-2020 · posted 2020-03-09 · Terminated

Recall details

Recalling firm

Micro Therapeutics Inc, Dba Ev3 Neurovascular

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.

Action taken

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.

Root cause

Process change control

Status

Terminated

Product code

OUT

Quantity affected

762

Distribution

Worldwide distribution. US nationwide, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hon

Date initiated

2020-02-14

Date posted

2020-03-09

Date terminated

2024-06-12

Location

Irvine, CA