Medtronic recalls custom perfusion tubing packs with Terumo OPS valves that may lack flow during cardiopulmonary bypass surgery. Affected units have specific lot/serial numbers listed in the recall.
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Medtronic is recalling custom perfusion tubing packs used in heart surgery that contain Terumo OPS valves with a reported lack of flow. This could lead to improper blood circulation during critical cardiac procedures.
The Terumo OPS valves in the tubing packs may not allow proper blood flow during cardiopulmonary bypass surgery. This could cause inadequate oxygenation or circulation of blood in the patient's system.
Surgical teams using Medtronic Custom Perfusion Systems during cardiopulmonary bypass procedures are most at risk. Patients undergoing heart surgery with these specific tubing packs may be affected.
Check the product's reference code (REF) and lot/serial numbers listed in the recall. The affected units include specific combinations of REF codes and serial numbers like 210937492 or 213801240.
Review the reference code (REF) and lot/serial numbers on your tubing pack to see if they match the affected units listed in the recall.
The recall is due to Terumo OPS valves in the tubing packs potentially lacking proper blood flow during cardiopulmonary bypass surgery.
Check the reference code (REF) and lot/serial numbers against the specific numbers listed in the recall notice.
The recall does not specify a remedy, so contact Medtronic directly for guidance on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0535-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0535-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
