NA 905Recalls & reported problems
St. Jude Medical, Inc. · Mechanical Heart Valve Sizer Set · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067042330), received between Jun 8, 2026 and Jun 8, 2026 — classified as 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Fracture
IT WAS REPORTED THAT ON 12 DEC 2025, A MECHANICAL VALVE SIZER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE PLASTIC FRACTURE AT THE HANDLE OF THE VALVE SIZER OCCURRED IN THE HOSPITAL. THE DISTRIBUTOR HAS CONFIRMED WITH THE HOSPITAL THAT THE HOSPITAL ADOPTS ONE OF THE DISINFECTION METHODS SPECIFIED IN THE CHINESE USER MANUAL OF THE VALVE SIZER. THE HOSPITAL INSPECTS THE VALVE SIZER FOR CRACKS AND DAMAGE BEFORE AND AFTER EACH DISINFECTION. SUBSEQUENTLY, THE SURGEON REPLACED THE VALVE SIZER AND VALVES WITH PRODUCTS FROM OTHER MANUFACTURERS TO COMPLETE THE OPERATION. THE PATIENT HAS RECOVERED AND BEEN DISCHARGED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25435920 ↗MalfunctionJun 8, 2026Fracture
IT WAS REPORTED THAT ON (B)(6) 2026, A MECHANICAL VALVE SIZER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE PLASTIC FRACTURE AT THE HANDLE OF THE VALVE SIZER OCCURRED IN THE HOSPITAL. THE DISTRIBUTOR HAS CONFIRMED WITH THE HOSPITAL THAT THE HOSPITAL ADOPTS ONE OF THE DISINFECTION METHODS SPECIFIED IN THE CHINESE USER MANUAL OF THE VALVE SIZER. THE HOSPITAL INSPECTS THE VALVE SIZER FOR CRACKS AND DAMAGE BEFORE AND AFTER EACH DISINFECTION. SUBSEQUENTLY, THE SURGEON REPLACED THE VALVE SIZER AND VALVES WITH PRODUCTS FROM OTHER MANUFACTURERS TO COMPLETE THE OPERATION. THE PATIENT HAS RECOVERED AND BEEN DISCHARGED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25435918 ↗
Other SIZER, HEART-VALVE, PROSTHESIS devices
- Simulus™ 850Medtronic, Inc. · SIZER, HEART-VALVE, PROSTHESIS1 recall0 reports
- Simulus™ 750Medtronic, Inc. · SIZER, HEART-VALVE, PROSTHESIS1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.