Aspira Drainage Kit 4992209Recalls & reported problems
Bard Access Systems, Inc. · Aspira Pleural/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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801741091145), received between Jul 14, 2017 and Jan 8, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Fluid/Blood Leak1
- Material Frayed1
- No Device Output1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
- Pneumothorax1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ACCOUNT ALLEGES THAT POST PROCEDURE OF A RIGHT PLEURAL CATHETER, THE LEFT CATHETER CAP BECAME DISLODGED ALLOWING PLEURAL FLUID TO DRAIN AND AIR TO BACKFLOW INTO THE CATHETER. THIS EVENT CAUSED A LEFT-SIDED PNEUMOTHORAX REQUIRING HOSPITALIZATION. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Pneumothorax
MAUDE report 18466551 ↗MalfunctionJun 7, 2018Material Frayed; Material Frayed
IT WAS REPORTED THAT AFTER FLUSHING THE DEVICE, THE INNER STYLET BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7580626 ↗MalfunctionApr 6, 2018Fluid/Blood Leak
IT WAS REPORTED THAT THE ASPIRA DRAINAGE CATHETER WAS LEAKING FROM THE HUB. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7404506 ↗MalfunctionJul 14, 2017No Device Output
IT WAS REPORTED TO MS&S, THAT THE ASPIRA CATHETER IS NOT DRAINING. FLUID IS PRESENT IN THE TUBING, BUT WILL NOT DRAIN INTO THE BAG. MS&S ADVISED THE COMPLAINANT THAT THE VALVE MAY BE DAMAGED AND NEED TO BE REPLACED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6715675 ↗
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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