Medtronic Custom Perfusion Systems: Flow Issues in CPB Valves
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.
Lower-risk recall
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/72171-medtronic-custom-perfusion-systems-flow-issues-in-cpb-valves.
Source Summary by GovInfoNow · govinfonow.com/recall/72171-medtronic-custom-perfusion-systems-flow-issues-in-cpb-valves · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0535-2018
Cite this page
“Medtronic Custom Perfusion Systems: Flow Issues in CPB Valves.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72171-medtronic-custom-perfusion-systems-flow-issues-in-cpb-valves. Based on FDA recall #Z-0535-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0535-2018%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Medtronic- Product
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB)- Category
Medical device
What to do — step by step
Check Product Details
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.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
FDA distribution: “DE, IA, CA and Japan” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Delaware, Iowa.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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.
- Official source: FDA Recall #Z-0535-2018 (January 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0535-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.