Skip to content

Custom Perfusion System HY7W83R4Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK HY7W83R4 UK ADULT · Class 2

All models of Custom Perfusion System (61)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169519343), received between Jun 20, 2023 and Jun 20, 2023 — classified as 1 malfunction.

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 18, 2026.

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.

  • MalfunctionJun 20, 2023Material Separation; Material Separation

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CARDIOPLEGIA LINE SPLIT. THE CARDIOPLEGIA TUBING WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. THERE WAS NO DAMAGE TO THE PACKAGING. THE OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17163210 ↗

Other PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE devices

All PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page