Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 21, 2013
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
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Inc. Cardiac Rhythm Disease Management recalled Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethyle… - a moderate-severity action.
Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethyle… was recalled by Medtronic Inc. Cardiac Rhythm Disease Management in August 21, 2013. Reason: Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited qu…. Check the official notice for the remedy. Verify recall #Z-1966-2013 with the FDA Devices before acting.
The recall
Medtronic Inc. Cardiac Rhythm Disease Management issued this moderate-severity FDA Devices recall-Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited qu….
- Moderate
- severity level
- 153 units
- affected scope
- Class II
- classification
- August 21, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1966-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1966-2013) was formally reported on August 21, 2013, with the manufacturer initiating the action on June 14, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Inc. Cardiac Rhythm Disease Management is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 153 devices..
The documented reason for this recall is: 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 e… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina, South Africa and Singapore.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
153 devices.
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1966-2013 |
| Date reported | August 21, 2013 |
| Date initiated | June 14, 2013 |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Firm location | Saint Paul, MN |
| Affected scope | 153 devices. |
| Distribution | Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina, South Africa and Singapore. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1966-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Inc. Cardiac Rhythm Disease Management. Units affected: 153 devices..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2013. Severity: Moderate. Recall number: Z-1966-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina, South Africa and Singapore..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1966-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 21, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.