Performa® B (REF 7757-2MP65)Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00884450766507), received between Feb 20, 2025 and Sep 9, 2026 — classified as 2 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Material Separation” (11 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation11
- Fracture6
- Fluid/Blood Leak3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Foreign Body In Patient3
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50689685 ↗MalfunctionAug 26, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459046 ↗MalfunctionAug 13, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235141 ↗MalfunctionJan 21, 2026Material Separation
CUSTOMER REPORTS THE CATHETER BROKE DURING PROCEDURE WHEN PRESSURE OF PSI 900 WAS APPLIED. THEY ALLEGE THE END BLEW COMPLETELY OFF. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24130114 ↗MalfunctionJan 21, 2026Material Separation
CUSTOMER REPORTS THE CATHETER BROKE DURING PROCEDURE WHEN PRESSURE OF PSI 1000 WAS APPLIED. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24130020 ↗MalfunctionJan 21, 2026Material Separation
CUSTOMER REPORTS THE HUB DISCONNECTED FROM CATHETER UPON USE WITH POWER INJECTOR (1100 PSI).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24130016 ↗MalfunctionDec 17, 2025Fracture; Fracture
THE ACCOUNT ALLEGES THAT DURING A POWER INJECTION AND THE HUB FROM THE CATHETER BROKE OFF. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831251 ↗MalfunctionDec 17, 2025Fracture; Fracture
THE ACCOUNT ALLEGES THAT DURING A POWER INJECTION AND THE HUB FROM THE CATHETER BROKE OFF. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830639 ↗MalfunctionJul 16, 2025Break; Fracture; Break; Fracture
THE ACCOUNT ALLEGES THAT THE CATHETER BROKE AT THE TOP. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22522768 ↗InjuryApr 1, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PEDIATRIC PROCEDURE, THE DEVICE WAS FOUND TO BE LEAKING FLUID BETWEEN THE HUB AND THE CATHETER CONNECTION, OUTSIDE THE PATIENT'S BODY. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21748826 ↗InjuryApr 1, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PEDIATRIC PROCEDURE, THE DEVICE WAS FOUND TO BE LEAKING FLUID BETWEEN THE HUB AND THE CATHETER CONNECTION, OUTSIDE THE PATIENT'S BODY. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21748823 ↗MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT THE DEVICE WAS FOUND TO BE LEAKING AT THE HUB. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21700184 ↗MalfunctionFeb 20, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE CATHETER BROKE AT THE HUB DURING A PROCEDURE IN THE HEART. NO PATIENT INJURY WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 21420478 ↗MalfunctionFeb 20, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE CATHETER BROKE AT THE HUB DURING A PROCEDURE IN THE HEART. NO PATIENT INJURY WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 21420477 ↗MalfunctionFeb 20, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE CATHETER BROKE AT THE HUB DURING A PROCEDURE IN THE HEART. NO PATIENT INJURY WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 21420476 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.