PerformaRecalls & reported problems across all models
Merit Medical Systems, Inc. · 46 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 93
- Deaths reported
- 1
- Injuries reported
- 48
- Recalls
- 0
We found 46 models of Performa by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 93 adverse event reports in the FDA's MAUDE database, received between Jan 12, 2018 and Sep 28, 2026 — classified as 1 death, 48 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Material Separation” (53 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Performa problems
Device problems
- Material Separation53
- Fracture52
- Adverse Event Without Identified Device or Use Problem11
- Break10
- Fluid/Blood Leak10
- Material Integrity Problem4
- Detachment of Device or Device Component3
- Burst Container or Vessel2
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- Foreign Body In Patient21
- Intimal Dissection3
- Vascular Dissection3
- Atrial Perforation2
- Insufficient Information2
- No Consequences Or Impact To Patient2
- Cardiac Arrest1
Performa models
46 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Performa® BCatheter, intravascular, diagnostic15 reports
- Performa® 00884450001431CATHETER, INTRAVASCULAR, DIAGNOSTIC10 reports
- Performa® 00884450002605CATHETER, INTRAVASCULAR, DIAGNOSTIC5 reports
- Performa® 00884450766552Catheter, intravascular, diagnostic5 reports
- Performa® 00884450004265CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Performa® 00884450005187CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Performa® BCatheter, intravascular, diagnostic3 reports
- Performa® CCatheter, intravascular, diagnostic3 reports
- Performa® 00884450002056CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Performa® 00884450002612CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Performa® 00884450002919CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Performa® 00884450005804CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Performa® 00884450035856CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Performa® BCatheter, intravascular, diagnostic2 reports
- Performa® BCatheter, intravascular, diagnostic2 reports
- Performa® BCatheter, intravascular, diagnostic2 reports
- Performa® 00884450000960CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450000984CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450001011CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450002469CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450002506CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450002544CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450002575CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450002902CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450003077CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450003121CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450003145CATHETER, INTRAVASCULAR, DIAGNOSTIC1 death1 report
- Performa® 00884450003282CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450003534CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450004098CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450004159CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450004500CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450010716CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450010952CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450011256CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450021095CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450026984CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450028940CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450043257CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450123515CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450161210CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450230039CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450269787CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450283134CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® 00884450356593CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Performa® BCatheter, intravascular, diagnostic1 report
Recent Performa adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923205 ↗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 ↗MalfunctionApr 27, 2026Fracture
THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE PERFORMA CATHETER EXPERIENCED HUB DETACHMENT. NO ADDITIONAL PATIENT OUTCOME INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25008486 ↗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 ↗MalfunctionMar 12, 2026Fracture
THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE CUSTOMER REPORTED THAT TWO DEVICES FROM THE SAME LOT EXPERIENCED HUB DETACHMENT AT THE SAME LOCATION. BOTH DEVICES REPORTEDLY BROKE AT THE SAME SPOT DURING USE. NO ADDITIONAL PATIENT OUTCOME INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24586785 ↗MalfunctionMar 9, 2026Fracture
ACCOUNT REPORTED DURING A PROCEDURE, THE PHYSICIAN FOUND THE CONNECTION OF THE HUB HANDLE WAS BROKEN. IT WAS CHANGED NEW ONE TO COMPLETE PROCEDURE. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24550718 ↗MalfunctionMar 4, 2026Break; Fracture; Material Separation; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING POWER INJECTION, THE HUB OF THE CATHETER BROKE OFF. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512944 ↗MalfunctionFeb 11, 2026Detachment of Device or Device Component
THE ACCOUNT ALLEGES ON WITHDRAWING CATHETER FROM PATIENT THE END CAME OFF. IT WAS SAFELY REMOVED WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312517 ↗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 ↗
Other Merit Medical Systems, Inc. products
- Aspira11 models · 36 reports · 10 recalls
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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