Z-1966-2013Class II

Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall...

Name: Z-1966-2013 Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall...
Creator: Medtronic Inc. Cardiac Rhythm Disease Management
Published: 2013-06-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-06-14 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. Cardiac Rhythm Disease Management began a recall of Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B... on 2013-06-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1966-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-14
Posted: 2013-08-14
Terminated: 2014-03-07
Recalling firm: Medtronic, Inc.
Product: Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a Carmeda coated option. The Carmeda coating is a BioActive surface that is non-leaching and provides a thromboresistant blood contact surface.
Product code: DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 153 devices.
Distribution: Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina, South Africa and Singapore.
Product codes and lots: Lot Numbers: 12635577 and 12637041 Updated infrormation on 9/6/13 to include Lot # 12645672

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1966-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1966-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-14

Product code DTM

K071253Class IIAffinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface, Model Cb4014Medtronic Vascular / cleared 2007-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)