Straight In/Out Pt Line Kit 902-00037Recalls & reported problems
Belmont Instrument Corporation · w/ 4.4L Reservoir · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00896128002213), received between Jan 6, 2021 and Jun 28, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Mar 31, 2025Class IIOpen, 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-1675-2025 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak2
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2024Leak/Splash; Leak/Splash
BELMONT RECEIVED MEDWATCH #MW5154726 ON MAY 30TH, 2024 HAVING BELOW EVENT DESCRIPTION: DURING THE HIPEC THE HEAT EXCHANGER DISPOSABLE SET BEGAN TO LEAK SHORTLY AFTER THE SECOND DOSE OF MITOMYCIN-C WAS ADMINISTERED. UPON QUICKLY NOTICING THE LEAK, THE HIPEC WAS PAUSED AND THE DISPOSABLE SET THAT WAS LEAKING WAS EXCHANGED WITH A NEW ONE. IT APPEARED TO BE LEAKING FROM A CONNECTION THAT COMES PREMADE / GLUED FROM THE MANUFACTURER- THE RED PIECE OF TUBING THAT IS CONNECTED TO THE TOP OF THE ROUND METAL HEAT EXCHANGER ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19637032 ↗MalfunctionSep 25, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE USER FACILITY REPORTED THAT THE HYPERTHERMIA PUMP DISPOSABLE SET LEAKED AT THE HEAT EXCHANGER DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12530889 ↗MalfunctionJan 6, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE USER FACILITY REPORTED THAT THE HYPERTHERMIA PUMP DISPOSABLE SET LEAKED WHILE IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11127915 ↗
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, 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-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
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 · each recall links to the FDA recall notice
- 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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