Performa® 00884450004500Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 13, 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 00884450004500), received between May 19, 2021 and May 19, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture1
- Material Separation1
Patient problems
- Cardiac Arrest1
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING AN ELECTIVE PULMONARY EMBOLISM THROMBECTOMY PROCEDURE, INITIATED BY AN INTERVENTIONAL CARDIOLOGIST, THE STRAIGHTENER ON THE 5F PERFORMA CARDIAC PIG-TAIL CATHETER WAS ACCIDENTALLY INTRODUCED INTO THE PATIENT'S VENOUS SYSTEM. AN ATTEMPT TO SNARE THE FOREIGN BODY FROM THE PATIENT WAS UNSUCCESSFUL. THE PATIENT CODED DURING THE PROCEDURE. HOSPITAL PROTOCOLS WERE ACTIVATED AND INITIATED TO STABILIZE THE PATIENT. THE PATIENT IS CURRENTLY NONRESPONSIVE. A COMPUTERIZED TOMOGRAPHY (CT) SCAN HAS BEEN ORDERED TO LOCATE THE FOREIGN BODY. THE MEDICAL STAFF BELIEVE THE FOREIGN BODY MAY HAVE MIGRATED NEAR OR WITHIN THE PATIENT'S HEART.
Patient problems: Cardiac Arrest; Foreign Body In Patient
MAUDE report 11849561 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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