HEAT EXCHANGER SET (1 Piece) 902-00006PRecalls & 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 00896128002145), received between Dec 4, 2019 and Oct 3, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED A LEAK IN THE HYPERTHERMIA PUMP DISPOSABLE. THE HEAT EXCHANGER COMPONENT DEVELOPED A LEAK AFTER THE FIRST CHEMO DRUG WAS ADDED. IT WAS CHANGED WITH THE SAME LOT NUMBER AND CASE CONTINUED UNEVENTFULLY. HOWEVER, THE DISPOSABLE EVENT IN THIS INCIDENT WAS DISCARDED DUE TO CONTAMINATION.
Patient problems: Insufficient Information
MAUDE report 20363173 ↗MalfunctionDec 4, 2019Fluid/Blood Leak; Fluid/Blood Leak
BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "A LEAK IN THE HEAT EXCHANGER IN THE DISTAL END FEW MINUTES AFTER THE BEGINNING OF THE CHEMOTHERAPY. THEY CHANGED THE KIT AND CONTINUED WITH PROCEDURE. THE SET WAS DISCARDED OF."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9413100 ↗
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-1674-2025 · Mar 31, 2025 · Open, ClassifiedHyperthermia 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-1676-2025 · Mar 31, 2025 · Open, ClassifiedStraight 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, ClassifiedStraight 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
- Level 1 HL-90Icu Medical, Inc. · Warmer, thermal, infusion fluid991 reports
- Level 1 HL-390Icu Medical, Inc. · Warmer, thermal, infusion fluid634 reports
- Level 1 L-70Icu Medical, Inc. · Warmer, thermal, infusion fluid1 recall385 reports
- 3-Spike Disposable Set (1 Piece) 903-00006PBelmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 recall1 death97 reports
- Rapid Infuser RI-2, 120V, 750 ml/min 903-00039Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid132 reports
- Level 1 L-70NIIcu Medical, Inc. · Warmer, thermal, infusion fluid114 reports
- Rapid Infuser RI-2, 120V, 1000ml/min 903-00037Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 death76 reports
- Hyperthermia Pump Procedure Kit 902-00045Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 recall4 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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