Safety recall
Medical
FDA
Is the Medtronic Affinity Pediatric Arterial Filter safe?
Medtronic Inc. Cardiac Rhythm Disease Management · Recalled Jun 14, 2013
No — the Medtronic Affinity Pediatric Arterial Filter was recalled on Jun 14, 2013 due to a safety issue. Recalled for a safety or quality concern — see details. If you have this product: Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Why it was recalled
Recalled for a safety or quality concern — see details.
What to do
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
View the official FDA recall →
This is an official recall published by FDA. Recall details are current as of 2026-06-25; verify the latest status at the source.
Medtronic Affinity Pediatric Arterial Filter: common questions
Is the Medtronic Affinity Pediatric Arterial Filter safe?
No. The Medtronic Affinity Pediatric Arterial Filter was recalled on Jun 14, 2013 due to a safety issue. Recalled for a safety or quality concern — see details.
Has the Medtronic Affinity Pediatric Arterial Filter been recalled?
Yes. The Medtronic Affinity Pediatric Arterial Filter was recalled on Jun 14, 2013. The recall was issued by FDA (recall ID Z-1966-2013).
Why was the Medtronic Affinity Pediatric Arterial Filter recalled?
Recalled for a safety or quality concern — see details.
What should I do if I have the Medtronic Affinity Pediatric Arterial Filter?
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Where can I find the official recall notice for the Medtronic Affinity Pediatric Arterial Filter?
The official FDA recall record is available
here. Always verify recall details with the official source.
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