ConcertoTM PV-14-30-HELIX (UDI 00847536033641)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536033641), received between Mar 5, 2021 and Feb 2, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionFeb 2, 2024Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE BOX WHERE THE INPUT CAME WAS SEALED. THE CORRESPONDING OPENING WAS MADE AND WHEN OPENING THE PA CKAGING, A COIL WAS OBSERVED OUTSIDE THE MANDREL. THE DEVICE WAS NOT USED SUCCESSFULLY. HEALTHCARE PROVIDER (HCP) PULLED IT OUT AND USED ANOTHER ONE. ALL PIECES WERE NOT ACCOUNTED FOR. THE INPUT WAS OUTSIDE THE MANDRIL. A NEW COIL WAS USED. NO ADDITIONAL TREATMENT WAS REQUIRED. THIS DEVICE WAS REPROCESSED. THE LUMEN WAS NOT FLUSHED PRIOR TO USE. INSTRUCTIONS FOR USE (IFU) WAS FOLLOWED DURING PREPARATION, PROCEDURE, AND POST PROCEDURE. PROPER TEMPERATURE WAS REACHED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT PERMANENT IMPAIRMENT OF A FUNCTION. THIS EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANESTHESIA WAS USED. HAND COMPRESSION WAS USED. THE VEIN CLOSED. 1 SEGMENT WAS TREATED. ADDITIONAL INFORMATION RECEIVED REPORTED CLARIFICATION THAT WHEN THE COIL WAS TAKEN FROM THE PACKAGING IT WAS DETACHED. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634256 ↗
• MalfunctionMar 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THE CONCERTO COIL DETACHED WHEN THE PHYSICIAN DID NOT DETACH ATTEMPT TO DETACH. VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANOTHER CONCERTO COIL WAS USED. NO SYMPTOMS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13665003 ↗
• MalfunctionMar 3, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE DETACHED. THE PHYSICIAN ALSO TRIED TO DETACH THE COIL MANUALLY. THE COIL WAS REPLACED, AND 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 ANEURYSM EMBOLIZATION. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13662144 ↗
• MalfunctionJun 4, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE COIL WAS BEING USED AS PER THE IFU; HOWEVER, THE COIL DID NOT DETACH FROM ITS WIRE WITH EITHER THE INSTANT DETACHER OR MANUAL METHOD. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939973 ↗
• InjuryMar 5, 2021Positioning Problem; Migration; Positioning Problem; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT RECEIVE ANY ANTIPLATELET REGIMEN.

  Patient problems: Aneurysm

  MAUDE report 11424037 ↗