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English, Hyperthermia Pump, 230V 902-00001ARecalls & reported problems

Belmont Instrument Corporation · Class 2

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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10896128002135), received between Aug 31, 2018 and Nov 2, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K152208); 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 18, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Infusion or Flow Problem1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 2, 2018Infusion or Flow Problem; Infusion or Flow Problem

    THE DISTRIBUTOR EMAILED THE FOLLOWING DETAILS ABOUT AN EVENT THAT OCCURRED INVOLVING A HYPERTHERMIA PUMP: "THE SYSTEM SUCTION REGULATOR IS NOT WORKING. WE ARE NOT ABLE TO MAINTAIN OUR RESERVOIR CONTENT AND THE FLUID KEEPS DEPLETING. WE HAVE USED 2 DIFFERENT TYPES OF SUCTION SOURCE AND BOTH SOURCES ARE WORKING PERFECTLY. WE HAVE INTERMITTENTLY TURNED ON THE SUCTION REGULATOR HOPING TO STABILIZE THE RETURN FLOW, THE SURGICAL TEAM HAS ALSO REOPENED THE PATIENT'S ABDOMEN, CHANGED ALL THE DISPOSABLES IN ORDER TO RECTIFY THE CONNECTION BUT NOTHING SEEMED TO WORK. IT TOOK US 2 HOURS, 5PM-7PM TO RECTIFY BUT IT ALL DID NOT WORK. TO MAKE THE STORY SHORT, HIPEC PROCEDURE HAS BEEN TERMINATED AND WILL ONLY BE DONE UNTIL A GOOD SYSTEM ARRIVES."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8035387 ↗
  • MalfunctionAug 31, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    THE USER FACILITY REPORTED THAT A "BURNT SMELL" WAS NOTED RIGHT AFTER THE START OF A PROCEDURE. ABOUT 3 TO 5 MINUTES LATER, THE UNIT DISPLAYED A "PUMP FAULT" ALARM MESSAGE AND "THE UNIT IMMEDIATELY STOPPED." WHEN THE UNIT WAS RETURNED TO THE DISTRIBUTOR, IT WAS NOTED THAT THERE WERE SCRATCHES ON THE UNIT AND MISPLACED PINS ON THE ROLLER PUMP ASSEMBLY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7839669 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152208. One submission often covers many models, so check the product and lot details in each record.

  • Z-1676-2025 · Mar 31, 2025 · Open, Classified
    Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient L
  • Z-1674-2025 · Mar 31, 2025 · Open, Classified
    Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) co
  • Z-1675-2025 · Mar 31, 2025 · Open, Classified
    Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line

Other Warmer, Thermal, Infusion Fluid devices

All Warmer, Thermal, Infusion Fluid devices →

Sources and updates

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