Aspira® 00884450394892Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 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, 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.
Recalls naming this device
- Apr 22, 2023Class IIOpen, 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 ↗
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
- PeritX 50-9050ACarefusion 2200, Inc · Peritoneal, drainage catheter for refractory ascites, long-term indwelling38 reports
- Aspira® 00884450394878Merit Medical Systems, Inc. · Peritoneal, drainage catheter for refractory ascites, long-term indwelling29 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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