X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-

FDA device recall Z-0310-2017 · posted 2016-11-09 · Terminated

Recall details

Recalling firm

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

DQX

Quantity affected

10,516 units

Distribution

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czec

Date initiated

2016-10-05

Date posted

2016-11-09

Date terminated

2017-10-11

Location

Irvine, CA