Aspira® 00884450394878Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
All models of Aspira (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Merit Medical Systems catheter is a long-term drainage catheter placed in the abdomen to drain fluid from ascites. The 29 reports describe drainage that slows or stops, connections that don't hold, the catheter coming out on its own, and the catheter breaking. No deaths and no injuries are reported. There are no recalls naming this device. All reports arrived in the past 12 months, where there had been none in the previous 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00884450394878), received between Apr 29, 2026 and May 1, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (22 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incomplete or Inadequate Connection22
- Device Dislodged or Dislocated14
- Break9
- Connection Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Device Dislodged or Dislocated; Incomplete or Inadequate Connection
NO INJURY WAS REPORTED. SUPPLEMENTAL REPORT SUBMITTED TO CORRECT THE INITIAL REPORT AFTER REASSESSMENT DETERMINED THE EVENT IS NOT REPORTABLE UNDER 21 CFR PART 803.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055189 ↗MalfunctionMay 1, 2026Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A FEMALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCING SLOW TO NO DRAINAGE OF THEIR CATHETER. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055188 ↗MalfunctionMay 1, 2026Device Dislodged or Dislocated
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCED THEIR CATHETER CAME OUT BY ACCIDENT. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055186 ↗MalfunctionMay 1, 2026Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCING SLOW TO NO DRAINAGE OF THEIR CATHETER. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055185 ↗MalfunctionMay 1, 2026Break; Device Dislodged or Dislocated; Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER WHERE THEY EXPERIENCED CATHETER BREAKAGE, SLOW TO NO DRAINAGE, AND IT CAME OUT BY ACCIDENT. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055168 ↗MalfunctionMay 1, 2026Device Dislodged or Dislocated; Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER WHERE THEY EXPERIENCED THE CATHETER HAVING SLOW TO NO DRAINAGE AND IT CAME OUT BY ACCIDENT. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055167 ↗MalfunctionMay 1, 2026Connection Problem; Device Dislodged or Dislocated
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCING DIFFICULTY WITH CONNECTIONS AND IT CAME OUT BY ACCIDENT. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055166 ↗MalfunctionMay 1, 2026Device Dislodged or Dislocated; Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A FEMALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCING SLOW TO NO DRAINAGE OF THEIR CATHETER AND IT CAME OUT BY ACCIDENT. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055164 ↗MalfunctionMay 1, 2026Device Dislodged or Dislocated
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER WHERE THEY EXPERIENCED THE CATHETER CAME OUT BY ACCIDENT. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055156 ↗MalfunctionMay 1, 2026Device Dislodged or Dislocated; Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A FEMALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCING SLOW TO NO DRAINAGE OF THEIR CATHETER AND IT CAME OUT BY ACCIDENT. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055152 ↗MalfunctionApr 30, 2026Break; Device Dislodged or Dislocated; Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER WHERE THE CATHETER WAS DAMAGED/ BROKEN, HAD SLOW TO NO DRAINAGE, AND WAS DISLODGED ON ACCIDENT. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048968 ↗MalfunctionApr 30, 2026Device Dislodged or Dislocated
A PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY STATED A MALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCED HIS CATHETER CAME OUT BY ACCIDENT. THE CATHETER'S DRAINAGE SITE WAS LOCATED IN THE ABDOMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048952 ↗MalfunctionApr 30, 2026Incomplete or Inadequate Connection
A PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY STATED A MALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCED SLOW TO NO CATHETER DRAINAGE. THE CATHETER'S DRAINAGE SITE WAS LOCATED IN THE ABDOMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048948 ↗MalfunctionApr 30, 2026Break; Device Dislodged or Dislocated; Incomplete or Inadequate Connection
A PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY STATED A MALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCED ISSUES WITH SLOW DRAINAGE OR NONE AT ALL, DAMAGE TO THE CATHETER SUCH AS BREAKING, AND THAT THE CATHETER CAME OUT BY ACCIDENT. THE CATHETER'S DRAINAGE SITE WAS LOCATED IN THE ABDOMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045572 ↗MalfunctionApr 30, 2026Incomplete or Inadequate Connection
NO INJURY WAS REPORTED. SUPPLEMENTAL REPORT SUBMITTED TO CORRECT THE INITIAL REPORT AFTER REASSESSMENT DETERMINED THE EVENT IS NOT REPORTABLE UNDER 21 CFR PART 803.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045569 ↗MalfunctionApr 30, 2026Incomplete or Inadequate Connection
A PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY STATED A MALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCED ISSUES WITH SLOW DRAINAGE OR NONE AT ALL. THE CATHETER'S DRAINAGE SITE WAS LOCATED IN THE ABDOMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045568 ↗MalfunctionApr 30, 2026Device Dislodged or Dislocated; Incomplete or Inadequate Connection
NO INJURY WAS REPORTED. SUPPLEMENTAL REPORT SUBMITTED TO CORRECT THE INITIAL REPORT AFTER REASSESSMENT DETERMINED THE EVENT IS NOT REPORTABLE UNDER 21 CFR PART 803.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045567 ↗MalfunctionApr 30, 2026Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A FEMALE PATIENT AGED 18 YEARS OR OLDER WHERE THE CATHETER HAD SLOW TO NO DRAINAGE. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045556 ↗MalfunctionApr 30, 2026Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER WHERE THE CATHETER HAD DIFFICULTY WITH THE CATHETER CONNECTIONS AND ABILITY TO DRAIN FLUID. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045552 ↗MalfunctionApr 29, 2026Break; Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCED DIFFICULTY WITH THE ABILITY TO DRAIN FLUID AND CATHETER BREAKAGE. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036477 ↗MalfunctionApr 29, 2026Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCED DIFFICULTY WITH THE ABILITY TO DRAIN FLUID. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036475 ↗MalfunctionApr 29, 2026Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCED DIFFICULTY WITH THE ABILITY TO DRAIN FLUID.. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036474 ↗MalfunctionApr 29, 2026Break; Connection Problem
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A FEMALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCED CATHETER BREAKAGE AND SLOW TO NO DRAINAGE. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036459 ↗MalfunctionApr 29, 2026Incomplete or Inadequate Connection
NO INJURY WAS REPORTED. SUPPLEMENTAL REPORT SUBMITTED TO CORRECT THE INITIAL REPORT AFTER REASSESSMENT DETERMINED THE EVENT IS NOT REPORTABLE UNDER 21 CFR PART 803.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036455 ↗MalfunctionApr 29, 2026Break; Incomplete or Inadequate Connection
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER EXPERIENCED SLOW TO NO DRAINAGE AND A BREAK IN THE CATHETER. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036454 ↗
Other Peritoneal, drainage catheter for refractory ascites, long-term indwelling devices
- PleurX 50-7510Carefusion 2200, Inc · Peritoneal, drainage catheter for refractory ascites, long-term indwelling2 deaths126 reports
- Aspira® 00884450398166Merit Medical Systems, Inc. · Peritoneal, drainage catheter for refractory ascites, long-term indwelling2 recalls0 reports
- Aspira® 00884450394908Merit Medical Systems, Inc. · Peritoneal, drainage catheter for refractory ascites, long-term indwelling1 recall2 reports
- Aspira® 00884450394892Merit Medical Systems, Inc. · Peritoneal, drainage catheter for refractory ascites, long-term indwelling1 recall0 reports
- PeritX 50-9050ACarefusion 2200, Inc · Peritoneal, drainage catheter for refractory ascites, long-term indwelling38 reports
- PeritX 50-9900CCarefusion 2200, Inc · Peritoneal, drainage catheter for refractory ascites, long-term indwelling15 reports
- PleurX 50-9050Carefusion 2200, Inc · Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling7 reports
- PeritX 50-9510Carefusion 2200, Inc · Peritoneal, drainage catheter for refractory ascites, long-term indwelling3 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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