Performa® 00884450028940Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450028940), received between Jan 7, 2021 and Jan 7, 2021 — classified as 1 injury.
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.
Most reported problems
Device problems
- Fracture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS INTERVENTIONAL PERIPHERAL VASCULAR PROCEDURE, THE CATHETER SHAFT DETACHED. THE PHYSICIAN HAD ACQUIRED RIGHT CONTRALATERAL RETROGRADE FEMORAL ARTERY ACCESS AND SUCCESSFULLY PLACE A 6F INTRODUCER SHEATH. THE PHYSICIAN HAD SUCCESSFULLY NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION UNDER FLUOROSCOPY WITH A GUIDEWIRE AND THE 5F CATHETER. DURING CATHETER MANIPULATIONS WITHIN THE PATIENT'S LEFT SUPERIOR FEMORAL ARTERY [SFA] THE CATHETER SHAFT DETACHED [MID SHAFT]. SECONDARY ACCESS WAS SUCCESSFULLY ACQUIRED, AND AN ADDITIONAL DIAGNOSTIC CATHETER WAS INTRODUCED AGAIN UNDER FLUOROSCOPY. DURING AN ATTEMPT TO RETRIEVE THE FIRST DETACHED CATHETER [FOREIGN BODY], THE SECOND CATHETER DETACHED AS WELL [MID SHAFT] AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT WHILE STILL ON THE GUIDEWIRE. THE ACCESS SHEATH WAS UPSIZED TO 8F TO ACCOMMODATE THE SUCCESSFUL RETRIEVAL OF THE PRIMARY FOREIGN BODY [CATHETER] VIA VASCULAR SNARE DEVICE. THE PHYSICIAN THEN PROCEEDED TO SUCCESSFULLY FINISH THE VASCULAR INTERVENTION WITHOUT ANY ADDITIONAL CONSEQUENCES TO REPORT. THE PATIENT TOLERATED THE PROCEDURE WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11135878 ↗
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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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