Sarns Cardioplegia SetRecalls & reported problems across all models
Terumo Cardiovascular Systems Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Sarns Cardioplegia Set model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of Sarns Cardioplegia Set by Terumo Cardiovascular Systems Corporation in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Sarns Cardioplegia Set recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 20, 2024Open, Classified
Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention
Z-1401-2024 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗
Sarns Cardioplegia Set models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sarns™ Cardioplegia Set 165720Heat-Exchanger, Cardiopulmonary Bypass1 recall0 reports
- Sarns™ Cardioplegia Set 16010Heat-Exchanger, Cardiopulmonary Bypass1 recall0 reports
- Sarns™ Cardioplegia Set 6375Heat-Exchanger, Cardiopulmonary Bypass1 recall0 reports
Other Terumo Cardiovascular Systems Corporation products
- Terumo Advanced Perfusion System 131 models · 1,869 reports · 11 recalls
- Cardiovascular Procedure Kit227 models · 92 reports · 2 recalls
- Capiox RX Hollow Fiber Oxygenator with Hardshell Reservoir6 models · 99 reports · 1 recall
- CDI Blood Parameter Monitoring System 5502 models · 75 reports
- CDI OneView Monitoring System3 models · 6 reports · 1 recall
- CDI Blood Parameter Monitoring System 5002 models · 39 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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