ConcertoTM PV-3-6-3D (UDI 00847536033733)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536033733), received between Jun 6, 2022 and May 10, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THREE CONCERTO COILS WOULD NOT ADVANCE IN MICROCATHETER VERY FAR BEFORE GETTING STUCK. ONLY WOULD ADVANCE JUST PAST THE HUB. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE PROXIMAL SECTION OF THE CATHETER. THE COIL (LOT # 227937283) DID PUSH SMOOTHLY OUT FROM THE INTRODUCER SHEATH. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288229 ↗
• MalfunctionNov 9, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS 2 CONCERTO COIL'S THAT DID NOT DEPLOY FROM THE CATHETER. THE CONCERTO COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18106181 ↗
• MalfunctionNov 9, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS 2 CONCERTO COIL'S THAT DID NOT DEPLOY FROM THE CATHETER. THE CONCERTO COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18106160 ↗
• MalfunctionNov 4, 2022Inadequacy of Device Shape and/or Size; Separation Failure; Physical Resistance/Sticking; Inadequacy of Device Shape and/or Size; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT 2 CONCERTO COILS GOT STUCK IN THE MICROCATHETER DURING DELIVERY. THE COILS DID NOT DETACH SUCCESSFULLY, AND THERE WAS COIL COMPACTION. THE COILS WERE REMOVED AND DID NOT CAUSE HARM TO THE PATIENT. SIX OTHER CONCERTO COILS WERE USED IN THE PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT FOR GASTROINTESTINAL BLEED EMBOLIZATION. THIS WAS NOT A RE-EMBOLIZATION PROCEDURE. ANCILLARY DEVICES INCLUDE A PROGREAT 2.4 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730662 ↗
• MalfunctionJun 6, 2022Break; Separation Failure; Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS NOT ABLE TO BE DETACHED. THE COIL WAS DETACHED MANUALLY WITH BREAKAGE AT THE DISTAL MARKER. THE FILAMENT BROKE OFF AND COMPLETELY JUMPED BACK INTO THE HUB. THERE WAS NO FILAMENT TO PULL IN ORDER TO DETACH. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR EMBOLIZATION OF THE RIGHT PROXIMAL RENAL ARTERY. THE DEGREE OF TORTUOSITY AND CALCIFICATION WAS SAID TO BE LITTLE. THERE WERE NO ABNORMALITIES WITH THE ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603336 ↗