Performa® 00884450002056Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Performa (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450002056), received between Feb 20, 2025 and Feb 26, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Separation1
- Partial Blockage1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A RENAL PROCEDURE ON REMOVAL THE TIP WAS FOUND TO HAVE BROKEN. THE LOOSE PART OF THE TIP WAS RETAINED IN THE RENAL PELVIS. THE TIP REMAINS WITHIN THE PATIENT AS SHE HAS A UTERAL STENT IN AND WILL LIKELY NEED FURTHER TREATMENT. THE DECISION WAS MADE THAT IT WAS NOT CLINICALLY SAFE TO REMOVE THE TIP AT THAT TIME AND PLANS ARE IN PLACE TO REMOVE THE TIP DURING THE NEXT PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 21468676 ↗InjuryFeb 20, 2025Partial Blockage; Partial Blockage
THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THERE WAS AN ADDITIONAL PIECE OF PLASTIC TUBING APPROXIMATELY 8CM LONG WITHIN THE LUMEN OF THE DEVICE. THE PLASTIC TUBING WAS INADVERTENTLY INSERTED INTO THE PATIENT AND HAD TO BE RETRIEVED ENDOSCOPICALLY. THERE IS NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21428699 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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