NA BB9N31R3Recalls & reported problems
Medtronic, Inc. · CUSTOM PACK BB9N31R3 GOOD SAM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000024406), received between Aug 27, 2021 and Aug 27, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
1 FDA recall record name this device's 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, 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
- Dec 12, 2022Class IIOpen, Classified
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
Z-1027-2023 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Separation1
- Misassembled During Installation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2021Material Separation; Misassembled During Installation; Material Separation; Misassembled During Installation
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THERE WAS A LOOSE CONNECTION POST CENTRIFUGAL CONE THAT CAME COMPLETELY UNDONE DURING THE CASE. THIS OCCURRED BEFORE CROSS CLAMP AND THE PERFUSIONIST WAS ABLE TO CLAMP THE TUBING QUICKLY AND RE-ATTACH THE TUBING TO THE CONNECTOR, DE-AIR AND RESUME BYPASS. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED: AIR DID NOT ENTER THE CIRCUIT. APPROXIMATELY 100 ML OF BLOOD WAS LOST AS A RESULT OF THE LEAK AND A TRANSFUSION WAS NOT REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12376383 ↗
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- Custom Perfusion System HY8L55R5Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE3 recalls3 reports
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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 · 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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