ConcertoTM PV-18-40-HELIX (UDI 00847536017108)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536017108), received between Nov 5, 2018 and Oct 7, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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. 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.

• MalfunctionOct 7, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL ENCOUNTERED RESISTANCE WITHIN THE CATHETER. THE COIL WAS NOTED TO HAVE BEEN DAMAGED. IT IS UNKNOWN IF THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE (IFU). NO OTHER INFORMATION IS AVAILABLE. THE MODEL AND LOT NUMBER OF THE MICROCATHETER THAT WAS USED IS UNAVAILABLE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9164962 ↗
• InjuryMar 11, 2019Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  MEDTRONIC RECEIVED INFORMATION THAT THE IMPLANT COIL PREMATURELY DETACHED AND WAS REMOVED FROM THE PATIENT. THE PUSHWIRE WAS NOT BENT OR BROKEN AND WAS DISCARDED. THE PHYSICIAN DID NOT REPOSITION THE COIL AND DID NOT ATTEMPT TO DETACH IT. THE PUSHWIRE WAS NOT ROTATED AND THERE WAS MENTION OF MIGRATION AFTER DEPLOYMENT. THE COIL WAS REMOVED WITH A SNARE DEVICE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S VASCULATURE WAS SEVERE IN TORTUOSITY AND THE PATIENT'S BLOOD FLOW WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8409297 ↗
• MalfunctionNov 28, 2018Separation Failure; Deformation Due to Compressive Stress; Separation Failure; Deformation Due to Compressive Stress

  MEDTRONIC RECEIVED A REPORT THE COIL WAS DELIVERED INTO THE GONADAL VEIN BUT THE PHYSICIAN DIDN'T LIKE HOW IT WAS POSITIONED SO THEY DECIDED TO RECAPTURE THE COIL IN THE SHEATH, REPOSITION. HOWEVER, WHEN THEY TRIED TO RELEASE IT, THE POLYPROPYLENE YARN WAS BROKEN AND PREVENTED RELEASE. IT WAS ALSO NOTED THAT THE DEVICE WAS JAMMED/WOULD NOT CLOSE. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WAS NO DEGREE OF VESSEL TORTUOSITY. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8111541 ↗
• MalfunctionNov 28, 2018Separation Failure; Deformation Due to Compressive Stress; Separation Failure; Deformation Due to Compressive Stress

  MEDTRONIC RECEIVED A REPORT THE COIL WAS DELIVERED INTO THE GONADAL VEIN BUT THE PHYSICIAN DIDN'T LIKE HOW IT WAS POSITIONED SO THEY DECIDED TO RECAPTURE THE COIL IN THE SHEATH, REPOSITION. HOWEVER, WHEN THEY TRIED TO RELEASE IT, THE POLYPROPYLENE YARN WAS BROKEN AND PREVENTED RELEASE. IT WAS ALSO NOTED THAT THE DEVICE WAS JAMMED/WOULD NOT CLOSE. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WAS NO DEGREE OF VESSEL TORTUOSITY. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8111497 ↗
• MalfunctionNov 5, 2018Migration; Migration

  MEDTRONIC RECEIVED INFORMATION THAT TWO MEDTRONIC IMPLANT COILS MIGRATED FROM THE TARGET LOCATION AND POSSIBLY CONTRIBUTED TO NEWLY DEVELOPED PULMONARY THROMBOSIS. PRIOR TO THE EVENT, THE TWO MEDTRONIC IMPLANT COILS WERE IMPLANTED IN THE INTENDED LOCATION; HOWEVER, THEY BOTH FELL OUT OF THE ANEURYSM AND MIGRATED AFTERWARDS. ONE IMPLANT COIL WAS FOUND IN THE VENA CAVA AND THE OTHER IMPLANT COIL WAS FOUND IN THE PULMONARY ARTERY. THE PHYSICIANS SUCCESSFULLY EXTRACTED BOTH IMPLANT COILS FROM THE PATIENT. THE COMPLICATION MENTIONED ABOVE AS NOTICED AT THE TIME. THE PATIENT REQUIRED ADDITIONAL HOSPITALIZATION TIME DUE TO THE RE-INTERVENTION AND ADMINISTRATION OF THE ANTICOAGULANTS. THE REPORTED DEVICES AND ACCESSORY DEVICES WERE REPORTED TO BE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT¿S VASCULATURE WAS MODERATE IN TORTUOSITY AND BLOOD FLOW WAS NORMAL.

  Patient problems: Thrombosis

  MAUDE report 8037672 ↗