Performa® B (REF 7757-2MP80SH)Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450770658), received between May 13, 2025 and Aug 28, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Material Separation2
- Break1
- Fluid/Blood Leak1
- Material Integrity Problem1
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.
InjuryAug 28, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING DEVICE USE, AS THE CATHETER APPROACHED THE AORTA, THE DISTAL END OF THE CATETHETER BROKE AND DETACHED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22913069 ↗MalfunctionAug 27, 2025Break; Fracture; Material Separation; Material Integrity Problem; Break; Fracture; Material Separation; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THEY OPENED A CATHETER AND TESTED IT ON THE TABLE. THE TIP OF THE CATHETER DETACHED AT THE JUNCTION BETWEEN THE BLUE AND WHITE PORTION OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909969 ↗MalfunctionMay 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT WHEN THE CATHETER WAS PLACED INSIDE OF THE PATIENT AND WHEN THE PHYSICIAN WAS CONNECTING THE POWER INJECTOR FOR A PICTURE, THERE WAS A LARGE AMOUNT OF AIR IN THE LINE. THE PHYSICIAN REMOVED THE CATHETER AND FLUSHED THE CATHETER AND IT WAS LEAKING AT THE HUB AGAIN. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22013714 ↗
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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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