EXTENSION SET 2N3357Recalls & reported problems
Baxter Healthcare Corporation · Micro-Volume Extension Set with 0.2 Micrometer Filter · Class 2
All models of EXTENSION SET (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00085412639338), received between May 29, 2026 and Aug 17, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device2
- Fluid/Blood Leak2
- Backflow1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288000 ↗MalfunctionAug 17, 2026Air/Gas in Device
It was reported that a Micro-Volume Extension Set with 0.2 Micrometer Filter exhibited air in the line. The issue was identified during a Normal Saline (NS) flush. The treatment was being administered through a peripheral intravenous (PIV) catheter when the infusion pump alarmed for a downstream occlusion. The line and IV site were assessed, and no occlusion was identified. Further evaluation of the medication line filter revealed the presence of air within the filter. The flush was stopped and the medication line was subsequently discarded. There was no report of patient injury or medical intervention associated with these events. No additional information is available at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280757 ↗MalfunctionAug 14, 2026Backflow; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246511 ↗MalfunctionMay 29, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET WITH 0.2 MICROMETER FILTER LEAKED FLUIDS FROM AN UNSPECIFIED LOCATION. THIS WAS DURING PATIENT INFUSION VIA AN ARTERIAL LINE. THE SYRINGE PUMP WAS PROGRAMMED TO DELIVER AT A RATE OF 0.5 ML/HOUR. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334204 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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