ConcertoTM PV-16-40-HELIX (UDI 00847536017078)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536017078), received between Apr 11, 2019 and Dec 13, 2023 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathDec 13, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ADDITIONAL INFORMATION RECEIVED FROM THE COMMUNICATING AUTHOR REPORTED THE PATIENT'S DEATH WAS NOT ASSOCIATED WITH THE CONCERTO COILS. IMPLANTED CONCERTO COILS: INCLUDED HELIX EV3 CONCERTO PV 1640 LOT A366207; HELIX EV3 CONCERTO PV 1640 LOT A357326; HELIX EV3 CONCERTO PV 1640 LOT A364247; HELIX EV3 CONCERTO PV 1640 LOT A364247; HELIX EV3 CONCERTO PV 1430 LOT A366201; HELIX EV3 CONCERTO PV 1430 LOT A374709; HELIX EV3 CONCERTO PV 1430 LOT A 378790; HELIX EV3 CONCERTO PV 1640 LOT A 366207 AS THERE WAS NO REPORTED MALFUNCTION AND THE ADVERSE EVENT IS NOT ASSOCIATED WITH THE MEDTRONIC DEVICE(S), THIS EVENT IS NO LONGER A REPORTABLE EVENT. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THE EVENT REPORTABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 18322614 ↗
• MalfunctionJan 5, 2021Separation Failure; Material Deformation; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE FAILED TO DETACH. THREE DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND A SECOND INSTANT DETACHER WAS NOT USED. IT WAS UNKNOWN IF MANUAL DETACHMENT ATTEMPTS WERE MADE. A COIL WAS USED IN THIS CASE TO AVOID AND OCCLUDE RETROGRADE BLOOD FLOW FROM THE RIGHT INTERNAL ILIAC ARTERY, AN OFF-LABEL USE. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11118782 ↗
• MalfunctionMay 12, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THE ANEURYSM MEASURED APPROXIMATELY 40X40 MM. THREE ATTEMPTS EACH WERE MADE WITH THE INSTANT DETACHER AND MANUAL METHODS. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT, AND NO DAMAGE WAS OBSERVED TO THE PUSHWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10048937 ↗
• MalfunctionApr 11, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO FAILED TO DETACH. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED, AORTIC ANEURYSM. THE MAX DIAMETER WAS 35 MM WITH A 10MM NECK. THE ANATOMY WAS MODERATE IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. DURING THE PROCEDURE, MULTIPLE COILS WERE PLACED. A CONCERTO COIL WAS THEN ATTEMPTED. AT DETACHMENT, THE COIL DID NOT DETACH AFTER TWO ATTEMPTS WITH AN INSTANT DETACHER AND ONE ATTEMPT USING THE MANUAL METHOD. THE COIL WAS REMOVED. THE PROCEDURE WAS CONTINUED. THERE WERE NO REPORTS OF PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8506587 ↗