Hyperthermia Pump Procedure Kit 902-00045Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00896128002589), received between Apr 28, 2019 and Feb 19, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 31, 2025Open, Classified

   Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

   Z-1674-2025 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2021Material Twisted/Bent; Material Twisted/Bent

  THE USER REPORTED THAT THE BELMONT HYPERTHERMIA PUMP PROCEDURE KIT HAD A KINK IN THE DRAINAGE TUBING AND WOULD NOT FLOW DURING SET UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350910 ↗
• MalfunctionDec 18, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND REPORTED THE FOLLOWING: "SORRY TO INFORM THAT WE HAVE FOUND A FAULTY/DEFECTIVE OF, 902-00045 BELMONT HYPERTHERMIA PUMP PROCEDURE PACK KIT DURING THE CASE ON (B)(6) 2020 IN (B)(6) MEDICAL CENTRE BY DR. (B)(6) IN (B)(6) (LOT: 2019-1113). WE DISCOVER THAT THE SOLUTION STARTS TO LEAK FROM THE MACHINE ONCE START PUMPING AND THERE IS A CRACK ON THE TUBING. THE CASE WAS CONTINUED BY REPLACING THE DISPOSABLE SET AND IT WAS DONE SMOOTHLY AFTER THAT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11041240 ↗
• MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  OUR DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "LEAKAGE OF CHEMO-SOLUTION FROM THE HEAT EXCHANGER SET WAS DISCOVERED DURING THE HIPEC TREATMENT CYCLE. WE HAVE REPLACED THE WHOLE CONSUMABLE SET CONTINUE THE HIPEC TREATMENT AND THE PROCEDURE WAS SMOOTH AFTER THAT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9205493 ↗
• MalfunctionApr 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  OUR DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "DURING A CASE THE SOLUTION KEEPS LEAKING OUT NEAR THE HEATER EXCHANGE. THEY HAVE CLEANED IT ONCE AND RESUMED THE PROCEDURE BUT THE PROBLEM PERSISTS. FINALLY, IT WAS SOLVED EVENTUALLY BY REPLACING THE SET WITH THEIR BACKUP SET. HENCE, THEY WOULD LIKE TO ASK TO HAVE A REPLACEMENT OF THE KIT. THEY ARE NOT ABLE TO RETURN THE DEFECTED SET SINCE IT IS ALREADY CONTAMINATED BY CHEMO SOLUTION."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8559627 ↗

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-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