NA BB8C43R12Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000253882), received between Aug 14, 2024 and Jan 21, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K171308); they may or may not involve this specific model.

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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE TABLE TRAYS WERE CRACKED. THE CRACKS WERE APPROXIMATELY 6 INCHES. A COMPLETE BREAK DID NOT OCCUR. THE STERILE BARRIER WAS DAMAGED. THERE WERE NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128242 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE TABLE TRAYS WERE CRACKED. THE CRACKS WERE APPROXIMATELY 6 INCHES. A COMPLETE BREAK DID NOT OCCUR. THE STERILE BARRIER WAS DAMAGED. THERE WERE NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128213 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE TABLE TRAYS WERE CRACKED. THE CRACKS WERE APPROXIMATELY 6 INCHES. A COMPLETE BREAK DID NOT OCCUR. THE STERILE BARRIER WAS DAMAGED. THERE WERE NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128202 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE TABLE TRAYS WERE CRACKED. THE CRACKS WERE APPROXIMATELY 6 INCHES. A COMPLETE BREAK DID NOT OCCUR. THE STERILE BARRIER WAS DAMAGED. THERE WERE NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128189 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE TABLE TRAYS WERE CRACKED. THE CRACKS WERE APPROXIMATELY 6 INCHES. A COMPLETE BREAK DID NOT OCCUR. THE STERILE BARRIER WAS DAMAGED. THERE WERE NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128183 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE TABLE TRAYS WERE CRACKED. THE CRACKS WERE APPROXIMATELY 6 INCHES. A COMPLETE BREAK DID NOT OCCUR. THE STERILE BARRIER WAS DAMAGED. THERE WERE NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128164 ↗
• MalfunctionJan 20, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE TABLE TRAYS WERE CRACKED. THE CRACKS WERE APPROXIMATELY 6 INCHES. A COMPLETE BREAK DID NOT OCCUR. THE STERILE BARRIER WAS DAMAGED. THERE WERE NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24117260 ↗
• MalfunctionJan 20, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE CUSTOM TUBING PACKS, IT WAS REPORTED THAT THE TABLE TRAYS WERE CRACKED. THE CRACKS WERE APPROXIMATELY 6 INCHES. A COMPLETE BREAK DID NOT OCCUR. THE STERILE BARRIER WAS DAMAGED. THERE WERE NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER DAMAGED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116509 ↗
• InjuryOct 2, 2024Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS A FLOW ISSUE WITH NO FLOW THROUGH THE VALVE AND IT WAS REPORTED THAT THERE WAS A BROKEN 1 WAY VALVE. THE PATIENT HAD PREVIOUSLY BEEN ON HEPARIN ANTI-COAGULANT THERAPY. THE ANTI-COAGULATION WAS ASSESSED WITH THE HMS PLUS INSTRUMENT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ONE WAY VALVE WAS NOT WORKING AS NO FLOW WAS PASSING THROUGH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352757 ↗
• MalfunctionAug 14, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A CRACK/BREAK LOCATED ON THE VENT ON THE SUCKER LINE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS A PARTIAL CRACK/BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19979631 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171308. One submission often covers many models, so check the product and lot details in each record.

• Z-0535-2018 · Jan 3, 2018 · Terminated
  Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.