Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13:

FDA device recall Z-1966-2013 · posted 2013-08-14 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

Reason for recall

Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.

Action taken

Customer communication was initiated verbally on June 14, 2013, to the 4 affected customers to quarantine any un-used units. An Urgent Medical Device Recall letter, dated June 26, 2013. was mailed to customers on June 28, 2013. The Urgent Medical Device letter referenced that the letter is in follow-up to the previous phone call. It identified the affected product, stated the issue with the 2 affected lot numbers and health risks, and asked that the affected devices be quarantined for return to Medtronic. If you have any questions please contact your Medtronic Sales representative or Lifeline Technical Services at 1-877-526-7890. 1-763-526-7890. Update: Customer communication to the newly identified customer was initiated verbally on August 20,2013, with the customer letter delivery beginning AUG 27, 2013. A Medtronic representative is available to facilitate the return of affected product.

Root cause

Employee error

Status

Terminated

Product code

DTM

Quantity affected

153 devices.

Distribution

Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina, South Africa and Singapore.

Date initiated

2013-06-14

Date posted

2013-08-14

Date terminated

2014-03-07

Location

Saint Paul, MN

Related 510(k) clearances