Performa® CRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450843017), received between Jul 31, 2025 and Mar 17, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel2
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026
PIGTAIL BACK END BROKE OFF WHILE BEING USED. NO HARM TO THE PATIENT AS THAT END WAS OUTSIDE THE PATIENT. IT WAS ABLE TO BE REMOVED WITHOUT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616618 ↗MalfunctionAug 4, 2025Burst Container or Vessel; Material Split, Cut or Torn; Burst Container or Vessel; Material Split, Cut or Torn
ON (B)(6) 2025 A HEALTH CARE PROFESSIONAL REPORTED A CATHETER BURST AND THE HUB DETATCHED ENTIRELY. NO PATIENT DETAILS OR ADVERSE EVENTS WERE REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22701487 ↗MalfunctionJul 31, 2025Burst Container or Vessel; Burst Container or Vessel
ON (B)(6) 2025 A CATHETER BURST DURING A PROCEDURE. THIS PRODUCT WILL NOT BE RETURNED AND NO PATIENT DETAILS OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676618 ↗
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- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
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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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