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.
What this means for you
Illness, injury, or structural failure has been reported. 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, nonpyro
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Category
- Medical Device — Cardiovascular
- Affected units
- 153
Distribution
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