-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices con

FDA device recall Z-0120-2016 · posted 2015-10-14 · Terminated

Recall details

Recalling firm

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Reason for recall

The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.

Action taken

The firm, Medtronic, sent a "Notification of Recall" letter dated 09/04/15 to its customers. The letter described the product, problem and actions to be taken. The firm's letter instructed that customers return the Pipeline Embolization Devices to Medtronic for replacement with the US version of product. The firm asks customers to take the following steps: 1) Stop using this product immediately. 2) Segregate this product from other Inventory. 3) Fill out the reply form and fax to the completed form directly to Customer Service at (800) 716-6700 or email to: andrew.schramm@medtronic.com. Customer Service will issue an RGA number for the return of the affected product back to Medtronic Neurovascular. 4) Upon receipt of an RGA number, write the RGA number on the FEDEX slip and send the product back to: Medtronic Neurovascular, Attention: Product Recall, 9775 Toledo Way, Irvine, CA 92618. Prepaid and preaddressed FEDEX slips are enclosed for convenience. 5. Once they receive the returned units, product replacement units will be shipped directly to customers. The local Neurovascular representative can also be available to assist in expediting the exchange of product. For any questions contact directly at 949-680-1340.

Root cause

Process control

Status

Terminated

Product code

OUT

Quantity affected

23 devices

Distribution

US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD. No foreign consignees.

Date initiated

2015-09-04

Date posted

2015-10-14

Date terminated

2017-05-18

Location

Irvine, CA