Aspira Valve Repair Kit 4992306Recalls & reported problems
Bard Access Systems, Inc. · Aspira Valve Repair Kit · Class 2 · Implant
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 00801741045059), received between Sep 13, 2017 and Sep 13, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (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.
Most reported problems
Device problems
- Detachment Of Device Component1
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2017Detachment Of Device Component; Fluid/Blood Leak
IT WAS REPORTED BY MS&S THAT THE NURSE CALLED AND STATED SHE HAD A PATIENT WHO HAS TWO ASPIRA PLEURAL DRAINAGE TUBES IN AND ONE OF THE VALVES "FELL OFF". SHE STATED THE PATIENT WAS ABLE TO FIND THE VALVE AND REPLACE IT. THE TUBES WERE PLACED IN (B)(6) AND (B)(6) 2017. THE PATIENT TOLD THE NURSE, "IT JUST FELL OFF AND I DIDN'T REALIZE UNTIL I FELT SOMETHING WET. I WAS ABLE TO FIND IT AND PUT IT BACK ON."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6861776 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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