Gardian 25 mm Syringe Filter 6094184Recalls & reported problems
Pall International Sàrl · 25mm syringe filter with 5.0 micron low protein binding Versapor® membrane · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05034480315472), received between Jun 19, 2024 and Jun 19, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Filtration Problem” (1 report).
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
- Filtration Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2024Filtration Problem; No Apparent Adverse Event; Filtration Problem; No Apparent Adverse Event
DESCRIBE THE EVENT OR PROBLEM: WHEN MAKING AN INTRATHECAL CHEMOTHERAPY AND FILTERING THE INGREDIENTS THE DISC FILTER MEMBRANE COMPLETELY DISINTEGRATED, BUT DID NOT REACH THE PATIENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : INTRATHECAL CHEMOTHERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566173 ↗
Other Filter, infusion line devices
- Medex MX20846R2Icu Medical, Inc. · Filter, infusion line1 recall0 reports
- NA 2N3350Baxter International Inc. · Filter, infusion line33 reports
- Medex FS116Icu Medical, Inc. · Filter, infusion line30 reports
- Medex MX448HFBIcu Medical, Inc. · Filter, infusion line27 reports
- INTERLINK 1C8740Baxter International Inc. · Filter, infusion line10 reports
- NA 2N3342Baxter International Inc. · Filter, infusion line8 reports
- FLUID SYSTEMS ACCESSORIES 2N3368Baxter Healthcare Corporation · Filter, infusion line5 reports
- Medex FS113Icu Medical, Inc. · Filter, infusion line3 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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