NA BB9B43R3Recalls & reported problems
Medtronic, Inc. · CUSTOM PACK BB9B43R3 PERFORMER · Class 2
Data updated Oct 13, 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 00643169876743), received between Jul 14, 2023 and Jul 14, 2023 — 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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Dec 12, 2022Open, 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 · FDA record ↗
Most reported problems
Device problems
- Material Separation1
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.
MalfunctionJul 14, 2023Material Separation; Material Separation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS CUSTOM TUBING PACK, IT WAS NOTED THAT THE MANIFOLD OF THE CARDIOTOMY VENOUS RESERVOIR (CVR) WAS BROKEN, AND THE AP40 DECOUPLED. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. THE AP40 WAS PART OF THE FOLLOWING CUSTOM TUBING PACK (MODEL # BB9B43R3 / LOT # 220383792). THERE WAS NO DAMAGE TO THE OUTER PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17323861 ↗
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- 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 HY9D36R1Medtronic, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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