ConcertoTM PV-8-30-3D (UDI 00847536033801)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536033801), received between Dec 2, 2021 and Apr 19, 2023 — classified as 3 malfunctions.

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

• MalfunctionApr 19, 2023Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking; Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT A CONCERTO COIL DEPLOYED PREMATURELY IN THE CATHETER AND COULD NOT BE DELIVERED DURING A PROCEDURE TO TREAT A SPLENIC ARTERIOVENOUS FISTULA. NO OTHER INFORMATION WAS REPORTED.

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

  MAUDE report 16769240 ↗
• MalfunctionFeb 16, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING A THERAPEUTIC COILING PROCEDURE TO TREAT A DEEP FEMORAL ARTERY BLEED. THE COIL DETACHED PREMATURELY FROM THE DISTAL END OF THE PUSHWIRE WITHOUT TRIGGERING. IT WAS NOT CERTAIN IF THE COIL BROKE OR SEPARATED AT THE DETACHMENT POINT. THERE WAS CONCERN THAT A FOREIGN BODY, SUCH AS A BROKEN SEGMENT OF COIL, COULD TRAVEL ANYWHERE IN THE PATIENT'S BODY FROM THE VESSEL AND CAUSE DAMAGE AND/OR OCCLUSIONS. THE CATHETER WAS REMOVED WITH THE COIL. IT WAS UNKNOWN IF THE DEVICES WERE PREPARE PER THE INSTRUCTIONS FOR USE (IFU), IF THERE WAS DAMAGE TO THE PUSHWIRE, IF THERE WAS ANY FRICTION OR OTHER DIFFICULTY DURING DELIVERY OF THE COIL, IF THE PUSHWIRE WAS ROTATED, IF CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE, OR IF THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL. HOWEVER, IT WAS NOTED THAT AN ATTEMPT HAD BEEN MADE TO DETACH THE COIL. IT WAS NOT REPORTED IF THE PATIENT EXPERIENCED ANY SYMPTOMS RELATED TO THE EVENT BUT WAS NOTED THAT THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545705 ↗
• MalfunctionDec 2, 2021Break; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE FELT DURING DELIVERY AND THE COIL WAS BROKEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE SUBCARINAL VASCULAR LOCATION WITH AN UNKNOWN MAX DIAMETER AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DOCTORS FOUND A PIECE OF BROKEN COIL WIRE WHEN THEY REMOVED THE INTRODUCER SHEATH FROM THE FEMORAL ARTERY AFTER COMPLETING THE PROCEDURE. SO THEY ARRANGED THE PATIENT TO DO ANOTHER CT SCAN AND THEY FOUND THAT THE COIL WIRE/FILAMENT WAS BROKEN AND RETAINED IN THE PATIENT. IT WAS DECIDED TO CUT DOWN THE GROIN AND ATTEMPT TO USE A SNARE AND REMOVE THE COIL FILAMENT. AFTER A FEW ATTEMPTS, PART OF THE COIL FILAMENT WAS REMOVED AND BROKEN INTO THREE PIECES. THERE WAS A SHORT SEGMENT OF THE COIL FILAMENT THAT COULD NOT BE REMOVED AND REMAINED IN THE PATIENT'S BODY. THE PATIENT'S CONDITION WAS FINE AND THERE WAS NO FURTHER TREATMENT NEEDED AT THE MOMENT. IT WAS THOUGHT THAT THE COIL FILAMENT WAS MAYBE DUE TO A PREMATURE DETACHMENT OF THE COIL DURING DELIVERY. THERE WAS STRONG RESISTANCE FELT DURING DELIVERY AND THE C

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12915838 ↗