NA CB7U79R12Recalls & reported problems
Medtronic, Inc. · CUSTOM PACK CB7U79R12 3/8 E · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000021924), received between May 2, 2019 and May 2, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2019Material Separation; Material Separation
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE CUSTOM TUBING PACK LINE 5 OF THE TUBING "POPPED OFF" OF CONNECTOR AND AIR WAS INTRODUCED TO THE PATIENT. PATIENT WAS TREATED WITH CPR FOR 7.5 MINUTES. THE CIRCUIT WAS DE-AIRED AND RE-INITIATED. PATIENT WAS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) DEPENDANT AND HAS AN OXYGEN SATURATION (SA02) OF 6.
Patient problems: Low Oxygen Saturation
MAUDE report 8572440 ↗
Other Pump, blood, cardiopulmonary bypass, non-roller type devices
- CENTRIMAG MOTOR 102956Thoratec Switzerland GmbH · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type2 recalls4 deaths591 reports
- Impella Impella 5.0 AIC Pump SetAbiomed, Inc. · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type3 recalls56 deaths256 reports
- 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
- Custom Perfusion System BB8T05R1Medtronic, 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 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page