ConcertoTM PV-18-40-HELIX (UDI 00847536033672)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536033672), received between Sep 13, 2019 and Nov 14, 2024 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE LESION CHARACTERISTICS WERE IN THE AORTA. THE PATIENT¿S VESSEL TORTUOSITY WAS NORMAL. THE RESISTANCE WAS IN THE DISTAL END OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. MANUAL DETACHMENT, IT DETACHED WITH ONE ATTEMPT TO REMOVE IT. NO DAMAGE TO THE PUSHWIRE WAS NOTED. THE COIL WAS REMOVED FROM PATIENT AT THE TIME OF SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20686400 ↗
• MalfunctionJan 23, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS NOT DETACHED DESPITE SEVERAL ATTEMPTS. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER AND MANUAL ATTEMPT VIA HYPOTUBE OVER 3 TIMES. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. ANOTHER CONCERTO COIL WAS USED AND THE PROCEDURE ENDED SUCCESSFULLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   ANCILLARY DEVICES INCLUDE A SHEATH, MICROCATHETER, AND GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223776 ↗
• MalfunctionDec 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL THAT PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTRODUODENAL ARTERY (GDA) ANEURYSM. VESSEL TORTUOSITY WAS SEVERE. THERE WERE NO OTHER ABNORMALITIES NOTED IN RELATED TO THE PATIENT'S ANATOMY. NO VESSEL CALCIFICATION OR STENOSIS WAS NOTED. IT WAS REPORTED THAT THE DEVICE WAS INSPECTED AND PREPARED PER THE INSTRUCTIONS FOR USE (IFU) WITH NO ISSUE IDENTIFIED. THE ANATOMY WAS VERY TORTUOUS AND THE MICROCATHETER WAS "PUSHED TO LIMITS" TO ACCESS THE ANEURYSM LOCATION. THE CONCERTO COIL DETACHED PREMATURELY WITHIN THE CATHETER. THE COIL WAS RETRIEVED AND REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949728 ↗
• MalfunctionSep 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DETACHED BY ITSELF FROM THE WIRE. A SNARE WAS USED TO REMOVE THE COIL, AND A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351189 ↗
• 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 12915882 ↗
• MalfunctionSep 17, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT 28 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND 7-8 WERE MADE WITH THE MANUAL METHOD. PRIOR TO THE NON-DETACHMENT THERE WERE NO ISSUES ENCOUNTERED, AND NO DAMAGE WAS OBSERVED TO THE PUSHWIRE AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493070 ↗
• MalfunctionJun 22, 2021Separation Failure; Material Deformation; Physical Resistance/Sticking; Separation Failure; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL BECAME STUCK IN THE SHEATH AND WAS REPLACED. NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS NEEDED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL WAS NOT COMPLETELY RELEASED, SO THE PHYSICIAN WITHDREW IT. THE PATIENT WAS UNDERGOING TREATMENT FOR GONADAL EMBOLIZATION. THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ANCILLARY DEVICES INCLUDE A REBAR 18 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE COIL FAILED TO DETACH ONCE DELIVERED TO THE TARGET SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12047068 ↗
• MalfunctionApr 23, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL EXPERIENCED RESISTANCE IN THE SHEATH AND PREMATURELY DETACHED WITHIN THE CATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR LEFT HYPOGASTRIC ARTERY EMBOLIZATION. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL T ORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE FIFTH COIL USED COULD NOT BE DELIVERED AS COMPLETE DISRUPTION OCCURRED WITHIN THE PROGREAT CATHETER. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE HAD BEEN NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED, AND THE EVENT DID NOT LEAD TO OR EXTEND HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PROGREAT 2.8FR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721239 ↗
• MalfunctionMar 26, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED IT SEEMED THERE WAS RESISTANCE EXPERIENCED WHEN THE PHYSICIAN DESCRIBED THE FEEL WITH THE USE OF THE SECOND COIL. THE CATHETER USED WAS A NON-MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575016 ↗
• InjuryMar 5, 2021Positioning Problem; Migration; Positioning Problem; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE FIVE CONCERTO COILS WERE FOUND TO HAVE MIGRATED AFTER DEPLOYMENT. THE PATIENT WAS UNDERGOING PRE-EVAR (ENDOVASCULAR ANEURYSM REPAIR) EMBOLIZATION OF SAC FEEDING VESSELS. IT WAS REPORTED THAT AT A FOLLOW-UP ON A EVAR PATIENT (PROCEDURE PERFORMED ON (B)(6) 2021) THE COILS IMPLANTED PRE-PROCEDURE MIGRATED AWAY FROM THE TARGET VESSEL LEAVING IT OPEN LETTING FLOW BACK INTO THE AAA SAC (ENDOLEAK TYPE II). END OF PROCEDURE IMAGING UNDER INJECTION HAD SHOWN THE PACKING TO BE STABLE IN PLACE. THE MIGRATION OCCURRED SOMETIME BETWEEN THE PROCEDURE END AND THE FOLLOW-UP. IT WAS NOTED THAT THE CONCERTO COILS WERE ALSO BACKED BY COOK PUSHABLE COILS AND THE ENTIRE PACKING WAS FOUND MIGRATED AWAY FROM ITS TARGETED LOCATION WHERE IT WAS INITIALLY IMPLANTED. THERE WAS NO KNOWN CAUSE FOR THE MIGRATION, AND THE ORIGINAL PROCEDURE WAS SAID TO BE SMOOTH AND SUCCESSFUL. THE PATIENT EXPERIENCED INJURY DUE TO THE ENDOLEAK TYPE II DUE TO COILS MIGRATION AND REOPENING OF SAC FEEDING VESSEL/S. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Aneurysm

  MAUDE report 11424091 ↗
• InjuryMar 5, 2021Positioning Problem; Migration; Positioning Problem; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE FIVE CONCERTO COILS WERE FOUND TO HAVE MIGRATED AFTER DEPLOYMENT. THE PATIENT WAS UNDERGOING PRE-EVAR (ENDOVASCULAR ANEURYSM REPAIR) EMBOLIZATION OF SAC FEEDING VESSELS. IT WAS REPORTED THAT AT A FOLLOW-UP ON A EVAR PATIENT (PROCEDURE PERFORMED ON (B)(6) 2021) THE COILS IMPLANTED PRE-PROCEDURE MIGRATED AWAY FROM THE TARGET VESSEL LEAVING IT OPEN LETTING FLOW BACK INTO THE AAA SAC (ENDOLEAK TYPE II). END OF PROCEDURE IMAGING UNDER INJECTION HAD SHOWN THE PACKING TO BE STABLE IN PLACE. THE MIGRATION OCCURRED SOMETIME BETWEEN THE PROCEDURE END AND THE FOLLOW-UP. IT WAS NOTED THAT THE CONCERTO COILS WERE ALSO BACKED BY COOK PUSHABLE COILS AND THE ENTIRE PACKING WAS FOUND MIGRATED AWAY FROM ITS TARGETED LOCATION WHERE IT WAS INITIALLY IMPLANTED. THERE WAS NO KNOWN CAUSE FOR THE MIGRATION, AND THE ORIGINAL PROCEDURE WAS SAID TO BE SMOOTH AND SUCCESSFUL. THE PATIENT EXPERIENCED INJURY DUE TO THE ENDOLEAK TYPE II DUE TO COILS MIGRATION AND REOPENING OF SAC FEEDING VESSEL/S. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Aneurysm

  MAUDE report 11424066 ↗
• MalfunctionSep 13, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WOULD NOT BE DETACHED WHEN PLACED IN THE PATIENT'S VESSEL. AS A RESULT IT WAS REMOVED AND REPLACED SUCCESSFULLY. IT IS UNKNOWN IF THE DEVICES WERE PREPARED PER THE IFU, INFORMATION REGARDING DETACHMENT ATTEMPTS, PATIENT ANATOMY ARE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ANCILLARY DEVICES INCLUDE A RENEGADE STC 2.4F MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9039795 ↗