AspiraRecalls & reported problems across all models
Merit Medical Systems, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
10 open recalls name at least one Aspira model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 10
We found 11 models of Aspira by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2021 and May 1, 2026 — classified as 3 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (22 reports).
10 FDA recall records name at least one of these models by its device identifier, 10 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Aspira recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 22, 2023Open, Classified
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1916-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2023Open, Classified
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1915-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2023Open, Classified
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1914-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2023Open, Classified
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1913-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2023Open, Classified
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1912-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2023Open, Classified
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1911-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2023Open, Classified
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1910-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2023Open, Classified
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1909-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2023Open, Classified
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1908-2023 · Root cause: Process control · Recall details · FDA record ↗
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1599-2022 · Root cause: Environmental control · names 2 of these models · Recall details · FDA record ↗
Most reported Aspira problems
Device problems
- Incomplete or Inadequate Connection22
- Device Dislodged or Dislocated14
- Break9
- Fracture4
- Material Separation3
- Connection Problem2
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Cancer1
- Foreign Body In Patient1
- Pneumothorax1
Aspira models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Aspira® 00884450398166Peritoneal, drainage catheter for refractory ascites, long-term indwelling2 recalls0 reports
- Aspira® 00884450394908Peritoneal, drainage catheter for refractory ascites, long-term indwelling1 recall2 reports
- Aspira® 00884450394915APPARATUS, SUCTION, PATIENT CARE1 recall2 reports
- Aspira® 00884450394946APPARATUS, SUCTION, PATIENT CARE1 recall2 reports
- Aspira® 00884450394861APPARATUS, SUCTION, PATIENT CARE1 recall1 report
- Aspira® 00884450394892Peritoneal, drainage catheter for refractory ascites, long-term indwelling1 recall0 reports
- Aspira® 00884450394939APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
- Aspira® 00884450394960APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
- Aspira® 00884450394984APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
- Aspira® 00884450398173APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
- Aspira® 00884450394878Peritoneal, drainage catheter for refractory ascites, long-term indwelling29 reports
Recent Aspira adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Merit Medical Systems, Inc. products
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
- HeartSpan5 models · 10 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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