ConcertoTM PV-3-8-3D (UDI 00847536033740)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536033740), received between May 26, 2021 and Nov 3, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2022Inadequacy of Device Shape and/or Size; Separation Failure; Physical Resistance/Sticking; Inadequacy of Device Shape and/or Size; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE COILS GOT STUCK IN THE MICROCATHETER TO CATHARIZE THE GASTRODUODENAL ARTERY USING A 0.018 WIRE. THE COILS WERE REMOVED FROM THE MICROCATHETER AND DID NOT CAUSE HARM TO THE PATIENT FROM EPIC. WHILE ADVANCING THE COIL PRIOR TO DEPLOYMENT, THE COIL MALFUNCTIONED WITHIN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721545 ↗
• MalfunctionOct 27, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT ONE CONCERTO COIL BECAME STUCK IN THE INTRODUCER SHEATH, AND ANOTHER CONCERTO COIL BECAME DAMAGED. IT WAS REPORTED THAT THE SECOND COIL USED COULD NOT BE ADVANCED OUT OF THE INTRODUCER SHEATH. ANOTHER COIL USED IN THE PROCEDURE WAS "NOT HUBBED UP" WHEN IT WAS BEING FED. THEY TRIED TO RECAPTURE THE COIL BUT IT WAS MANGLED. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A REBAR 18 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680913 ↗
• MalfunctionSep 20, 2022Separation Failure; Material Deformation; Physical Resistance/Sticking; Separation Failure; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT'S VESSEL TORTUOSITY WAS MODERATE, AND THE COILS HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE MICROCATHETER USED IN THE EVENT WAS A PROGREAT 2.8FR. NO DETACHMENT ATTEMPTS WERE MADE AS THE COILS GOT STUCK INSIDE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456875 ↗
• MalfunctionMay 13, 2022Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE WITH 4 CONCERTO COILS AND THE COIL WOULDN'T DETACH. THE PATIENT WAS UNDERGOING TREATMENT FOR PROSTATIC ARTERY EMBOLIZATION (PAE). THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT TWO COILS WERE STUCK IN THE PROXIMAL PART OF THE MICROCATHETER, ONE WAS STUCK IN THE CATHETER HUB, AND ONE WAS STUCK IN THE DISTAL PART OF THE CATHETER. THE COILS HAD PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO DAMAGE TO THE CATHETER OR COILS. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399492 ↗
• MalfunctionDec 7, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WOULD NOT DEPLOY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12956900 ↗
• MalfunctionMay 26, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE COIL WOULD NOT MOVE INTO THE MICROCATHETER FROM THE INTRODUCER SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR A Y90 EMBOLIZATION. IT WAS NOTED THE VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882332 ↗