Medtronic Recalls Pediatric Arterial Filters Due to Potential Media Breach
Medtronic is recalling 148 Affinity Pediatric Arterial Filters because a small breach in the filter media may allow unwanted particulate or gaseous emboli to pass through, posing a risk of serious injury or death to pediatric patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the defect could result in 'serious injury to a pediatric patient including neurological damage, or potential patient death.' This aligns with the rubric criterion for 'significant injury/property-damage reports' or risk of serious harm, warranting a Severe classification.
Plain-English summary
Medtronic is recalling 148 Affinity Pediatric Arterial Filters from two manufacturing lots. The recall is due to a limited quantity of filters that may have a small breach in the filter media. This defect may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device.
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. The devices are available in uncoated and Carmeda coated options. The recall includes specific lot numbers: 12635577, 12637041, and 12645672.
The potential breach in the filter media could result in serious injury to a pediatric patient, including neurological damage, or potential patient death. The devices were distributed worldwide, with US distribution limited to Mississippi and Illinois, and distribution to Argentina, South Africa, and Singapore. Healthcare providers and facilities should stop using these devices and contact Medtronic for further instructions.
The recalled product
- 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…
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Category
- Medical Device — Cardiovascular
- Affected units
- 153
Distribution
Related recalls
Same manufacturer · Medtronic Inc. Cardiac Rhythm Disease Management
See all →- ModerateMedtronic SureScan Pacemaker ID Cards Mislabel MR Conditional Status
FDA (Devices) · 2015-10-14
- HighMedtronic CryoConsole Recalled Due to USB Component Issue
FDA (Devices) · 2015-09-23
- SevereMedtronic Temporary Pacemaker Recalled for Battery Connection Failure
FDA (Devices) · 2015-04-08
- ModerateMedtronic Recalls Trellis 6 and 8 Peripheral Infusion Systems for Sterility Breach
FDA (Devices) · 2015-04-08
- SevereMedtronic FlexCath Select Steerable Sheath Recalled for Valve Debris
FDA (Devices) · 2015-03-25
Same hazard · embolism
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- SevereReprocessed Electrophysiology Catheters Recalled for Residual Particles
FDA (Devices) · 2026-07-08
- HighDuraflow 2 vascular catheter kit recalled for loose metal shavings
FDA (Devices) · 2024-05-15
- HighHemodialysis Vascular Access Kit Recalled for Loose Metal Shavings
FDA (Devices) · 2024-05-15
- HighHemodialysis vascular access kit recalled for loose metal shavings
FDA (Devices) · 2024-05-15
Similar recalls
- ModerateMedtronic Affinity Arterial Filter Recalled for Excess Plastic Flash
FDA (Devices) · 2019-12-25
- ModerateMedtronic Recalls Affinity Fusion Oxygenators Due to Plastic Flash Defect
FDA (Devices) · 2016-12-28
- HighMedtronic Recalls Affinity NT Cardiotomy Reservoirs Due to Sterile Barrier Breach
FDA (Devices) · 2018-02-28
- HighMedtronic Arteriotomy Cannula Recall Due to Potential Unsealed Sterile Packing
FDA (Devices) · 2024-05-22
- HighMedtronic Recalls Amphirion Deep PTA Balloon Catheters Due to Seal Breach
FDA (Devices) · 2015-11-18
- HighMedline Arterial Line Insertion Kits Recalled for Sterility Breach
FDA (Devices) · 2026-09-09