ConcertoTM PV-2-6-3D (UDI 00847536033719)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536033719), received between Sep 24, 2020 and Feb 4, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CONCERTO COIL DID NOT DETACH WHEN ATTEMPTED. NO PATIENT INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303214 ↗
• MalfunctionMay 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO CATHETER HAD ISSUES WITH THE CATHETER. 4 COILS OF THE SAME SIZE WITH THE SAME LOT. DESPITE THE Y CONNECTOR AND IRRIGATION, THE TERUMO PROGREAT 2.4FR MICROCATHETER COULD NOT BE USED, AND A 2.8FR TERUMO MICROCATHETER WAS ALSO UNSUCCESSFUL. THE PATIENT IS ALIVE WITH NO INJURY. NO OTHER INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CONCERTO COILS COULD NOT BE PUSHED OUT, EVENT FLUSHING OR CHANGE TO A BIGGER SIZE PROGREAT 2.8F DID NOT SOLVE THE PROBLEM. THERE WAS NO OBVIOUS DEVICE ISSUE AND NOT PATIENT/THERAPY OR PROCEDURE ISSUE. CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391401 ↗
• MalfunctionApr 19, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. AN INSTANT DETACHER WAS NOT USED. THERE WERE 3 ATTEMPTS AT MANUAL DETACHMENT. THERE WERE NO ISSUES PRIOR TO COIL NON DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142263 ↗
• MalfunctionApr 4, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT ONE COIL WOULD NOT ADVANCE OUT OF THE CLEAR INTRODUCER SHEATH AND THE SECOND COIL WOULD NOT DETACH. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041223 ↗
• MalfunctionSep 20, 2022Separation Failure; Material Deformation; Physical Resistance/Sticking; Separation Failure; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT REGARDING 3 CONCERTO COILS THAT HAD RESISTANCE IN THE MIDDLE OF THE CATHETER. THE FIRST COIL (MODEL: PV-3-8-3D, LOT: B258906) WAS DIFFICULT TO DETACH BUT WAS ABLE TO BE DEPLOYED AND DETACHED. THE SECOND AND THIRD COIL HAD THE SAME RESISTANCE DURING DELIVERY AND COULD NOT BE DETACHED. IT WAS NOTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE CATHETER BUT THE COILS WERE DAMAGED. IT WAS NOTED THERE WAS NO ISSUE WITH THE INSTANT DETACHER. A COMPETITOR'S PRODUCT WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT GI BLEED. THERE WERE NO ABNORMALITIES NOTED WITH THE PATIENT'S ANATOMY. THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT PERMANENT PATIENT IMPAIRMENT. THE EVENT DID NOT EXTEND THE PATIENT'S HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456904 ↗
• MalfunctionJul 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED A REPORT THAT 3 CONCERTO COILS WERE "DEFECTIVE" AND WERE NOT IMPLANTED. THERE WERE NO ABNORMALITIES RELATED TO THE PATIENT'S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988580 ↗
• MalfunctionJun 27, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL COULD NOT BE FLUSHED. EVEN IF THEY FLUSHED, USED A Y CONNECTOR ON MICRO CATHETER TERUMO PROGREAT 2.4FR. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14825219 ↗
• MalfunctionSep 24, 2020Break; Break

  IT WAS REPORTED THERE WAS COIL SEPARATION WITH TWO COILS. NO ADDITIONAL EVENT DETAILS WERE PROVIDED AT THE TIME OF THE REPORT. REFER TO MANUFACTURER REPORT 2029214-2020-00963 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10579862 ↗
• MalfunctionSep 24, 2020Break; Break

  IT WAS REPORTED THERE WAS COIL SEPARATION WITH TWO COILS. NO ADDITIONAL EVENT DETAILS WERE PROVIDED AT THE TIME OF THE REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10579841 ↗