Straight Inflow/Bifurcated Outflow Pt Line Kit 902-00038Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00896128002220), received between Nov 7, 2019 and Feb 28, 2020 — 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.

Recalls naming this device

1. 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-1676-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  BELMONT'S DISTRIBUTOR IN THE (B)(4) RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "LEAKAGE INCIDENT, HIPEC CASE ON (B)(6) 2020. HYPERTHERMIA SET WAS INSTALLED. AFTER THE WARMING PHASE WAS RUN THROUGH THE CHEMOSTATIC AGENT WAS ADDED TO THE FLUID. DURING THE CHEMOPERFUSION A LEAK WAS NOTICED. THE LEAK WAS SMALL AND IT WAS DECIDED TO CONTINUE THE PROCEDURE SINCE IT WOULD BE MORE DANGEROUS TO EXCHANGE THE SET WITH REGARDS TO EXPOSURE OF PERSONNEL TO CHEMO. THE CHEMO CONTAMINATED DISPOSABLE WAS PRESERVED IN DOUBLE PACKAGING FOR BELMONT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9772079 ↗
• MalfunctionFeb 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "HYPERTHERMIA SET WAS INSTALLED AND THE WARMING PHASE HAD BEGUN. DURING THE WARMING PHASE IT WAS NOTICED FLUID WAS LEAKING FROM THE DISPOSABLE. IT WAS LEAKING FROM THE HEAT EXCHANGER. FORUTNATELY THE CHEMOSTATIC SOLUTION HAD NOT BEEN APPLIED YET. THE DISPOSABLE WAS REPLACED AND THE CASE CONTINUED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9742521 ↗
• MalfunctionNov 7, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  OUR DISTRIBUTOR RECEIVED A COMPLAINT FROM A USER FACILITY AND RELAYED THE FOLLOWING REPORT: IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD A FAULTY/DEFECTIVE BIFURCATED PATIENT LINE DISPOSABLE DURING A CASE ON 07OCT2019 IN THAILAND. ONE OF THE FOUR BIFURCATED TUBES (OUTFLOW) LOOKED ABNORMAL RIGHT AFTER OPENING THE SET, BUT THEY PROCEEDED WITH THE CASE USING THE IMPLICATED SET. A SHORT TIME INTO THE PROCEDURE THE TUBE BECAME COMPLETELY BLOCKED; THE DOCTOR PAUSED THE TREATMENT AND OPENED THE TUBE USING A NEEDLE. (THEIR COMMENT IS THAT IT LOOKS LIKE A HARD GLUE BLOCKING THE TUBE). THEY RECONNECTED EVERYTHING AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9293991 ↗

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, 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