Custom Perfusion System HY6Y19R5Recalls & reported problems
Medtronic, Inc. · CUSTOM PACK HY6Y19R5 PERF · Class 2
All models of Custom Perfusion System (61)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jan 3, 2018Class IITerminated
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Z-0535-2018 · Root cause: Component change control · Recall details · FDA record ↗
- Feb 4, 2016Class IIITerminated
Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.
Z-1023-2016 · Root cause: Component design/selection · Recall details · FDA record ↗
Other PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE devices
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- CentriMag™ 102953Thoratec Switzerland GmbH · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type1 recall35 deaths209 reports
- Impella Impella LD AIC Pump SetAbiomed, Inc. · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type3 recalls9 deaths57 reports
- NA HY8M65R2Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE4 recalls0 reports
- Custom Perfusion System HY8L55R5Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE3 recalls3 reports
- Custom Perfusion System BB6U40R11Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE2 recalls1 report
- NA BB8C33R6Medtronic, Inc. · Pump, blood, cardiopulmonary bypass, non-roller type2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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