Concerto Versa™ CV-12-50 (UDI 00763000936761)Recalls & reported problems
Medtronic, Inc. · COIL CONCERTO VERSA CV-12-50 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000936761), received between Jul 2, 2026 and Jul 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Material Deformation1
- Physical Resistance/Sticking1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Difficult to Remove; Material Deformation; Physical Resistance/Sticking; Premature Separation
IT WAS REPORTED THAT A 12X50 CONCERTO VERSA COIL WAS USED DURING AN EMBOLIZATION PROCEDURE TO TREAT AN UNDERPERFUSED TIPS STENT IN THE PATIENTS HEPATIC VARIX. MINIMAL VESSEL TORTUOSITY WAS REPORTED. A 5FR NON-MEDTRONIC (KA2 MERIT MEDICAL) DIAGNOSTIC CATHETER AND A 4CM 6FR NON-MEDTRONIC (TERUMO) SHEATH WERE USED. THE DEVICE WAS PREPPED PER THE IFU WITHOUT ISSUE. TRACKING DIFFICULTY WAS NOTED DURING INITIAL ADVANCEMENT, AND RESISTANCE WAS ENCOUNTERED AT THE CATHETER HUB AS THE COIL ADVANCED WITHIN THE (KMP) CATHETER. PHYSICIAN USED THE CHEATER TO ADD SUPPORT. PHYSICIAN MAY HAVE KINKED THE PUSHER/RELEASE WIRE AT SOME POINT BEFORE USING THE CHEATER. THE IMPLANT COIL WAS STRETCHED. A CONTINUOUS HEPARINIZED SALINE FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. DURING AN ATTEMPTED SINGLE REPOSITIONING, THE COIL DID NOT PULL BACK WITH THE PUSHER AND THE COIL DETACHED PREMATURELY DURING TRACKING INSIDE THE MICROCATHETER/DIAGNOSTIC CATHETER. PHYSICIAN TRIED TO USE THE CATHETER TO PACK IT IN BUT WASN¿T WORKING WELL, PHYSICIAN THEN TRIED TO JUST PULL THE SYSTEM BACK BUT THE COIL WASN¿T COMING WITH THE CATHETER. THE COIL WAS RETRIEVED AND REMOVED WHILE MAINTAINING SHEATH ACCESS BY USING REPEA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25688443 ↗
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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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