Aspira Drainage Kit 4992207Recalls & reported problems
Bard Access Systems, Inc. · Aspira Peritoneal Drainage Kit · Class 2 · Implant
All models of Aspira Drainage Kit (4)
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 10801741091121), received between Sep 20, 2017 and Sep 20, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper Device Output” (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
- Improper Device Output1
Patient problems
- Dyspnea1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2017Improper Device Output
PER MS AND S, THE HOSPICE NURSE CALLED TO REPORT DRAINAGE ISSUES WITH A PATIENT'S ASPIRA CATHETER. AFTER PLACEMENT, HE DRAINED ~1,000 CC. DURING THE LAST TWO DRAINAGE SESSIONS, HE DRAINED ~ 600 CC EACH TIME. TODAY, HE ONLY DRAINED ~ 10 CC. HE EXPERIENCES SHORTNESS OF BREATH EVEN WHEN HE HAS BEEN ABLE TO DRAIN, BUT HIS SHORTNESS OF BREATH IS WORSE SINCE HE ISN'T GETTING MUCH FLUID OUT. THEY TRIED 2 DRAINAGE KITS, BUT THE BULB DID NOT EXPAND AFTER SQUEEZING IT.
Patient problems: Dyspnea
MAUDE report 6880290 ↗
Other CATHETER, PERITONEAL, LONG-TERM INDWELLING devices
- Argyle 8811313010Mozarc Medical US LLC · CATHETER, PERITONEAL, LONG-TERM INDWELLING1 death75 reports
- Aspira Drainage Kit 4992301Bard Access Systems, Inc. · CATHETER, PERITONEAL, LONG-TERM INDWELLING1 recall4 reports
- Flex-Neck® 00884450170069Merit Medical Systems, Inc. · CATHETER, PERITONEAL, LONG-TERM INDWELLING1 recall0 reports
- Flex-Neck® 00884450305850Merit Medical Systems, Inc. · Catheter, peritoneal, long-term indwelling1 recall0 reports
- Argyle 8888415604Mozarc Medical US LLC · Catheter, peritoneal, long-term indwelling48 reports
- Argyle 8888423103Mozarc Medical US LLC · Catheter, Peritoneal, Long-Term Indwelling42 reports
- Argyle 8888411405Mozarc Medical US LLC · CATHETER, PERITONEAL, LONG-TERM INDWELLING33 reports
- Argyle 8888413807Mozarc Medical US LLC · CATHETER, PERITONEAL, LONG-TERM INDWELLING16 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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