ConcertoTM NV-6-20-HELIX (UDI 00847536013582)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536013582), received between Jan 4, 2019 and Jul 5, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2022Detachment 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 PREMATURELY DETACHED AND EXPERIENCED RESISTANCE IN THE DISTAL PART OF THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR COIL EMBOLIZATION. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MOD ERATE. IT WAS REPORTED THAT WHILE ADVANCING THE COIL THROUGH THE MICROCATHETER AND ~2/3 OF THE COILS PLACED IN THE TARGET VESSEL THE COIL PREMATURELY DETACHED FROM THE PUSHER. WHEN TRYING TO PUSH THE COIL FURTHER IT WOULD NO LONGER ADVANCE. THE MICROCATHETER WAS PULLED OUT AND THEY TRIED TO PUSH THE COIL THROUGH THE DIAGNOSTIC CATHETER, BUT THE COIL ADHERED TO THE CATHETER AND WOULD NOT ADVANCE. EVENTUALLY THE CATHETER WAS PULLED OUT ALTOGETHER PULLING THE COIL OUT WITH IT AND ACCESS WAS LOST. THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO DAMAGE TO THE CATHETER. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE HAD BEEN NO FRICTION/DIFFICULTY DURING DELIVERY, AND THE PHYSICIAN DID NOT REPOSITION THE COIL. NO DETACHMENT ATTEMPTS HAD BEEN MADE, THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE, AND A CONTINUOUS FLUSH WAS NOT ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY, SYMPTOMS, OR ADD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14918429 ↗
• MalfunctionJun 4, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DID NOT DETACH FROM ITS WIRE. BOTH THE MANUAL METHOD AND THE INSTANT DETACHER WERE USED. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11940263 ↗
• MalfunctionApr 30, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THREE COILS FAILED TO DEPLOY. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A TYPE II ENDOLEAK AFTER EVAR PROCEDURE. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE VESSEL TORTUOSITY WAS UNKNOWN. NO PATIENT INJURY WAS REPORTED. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. REBAR 027 MICROCATHETER ¿ HOSPITAL DISCARDED ALL THE COMPLAINT GOODS DUE TO THE CONCERN OF SPREAD OF CORONAVIRUS. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE COIL WAS STILL ATTACHED WHEN SHOWN UNDERX-RAY FOR 3 COILS. THERE WAS NO RESISTANCE FELT IN THE CATHETER. A CONTINUOUS FLUSH WAS NOT USED, BUT THE CATHETER WAS FLUSHED PRIOR TO THE COIL ENTERING. THE PROCEDURE WAS COMPLETED USING REPLACEMENT COILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10014600 ↗
• MalfunctionFeb 7, 2020Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL PREMATURELY DETACHED IN THE MICROCATHETER DURING DELIVERY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN POSTERIOR-LATERAL WALL OF AORTA BETWEEN SMA AND RIGHT RENAL ARTERY WITH A MAX DIAMETER OF 30MM AND A 0.6-0.7MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT WHILE ADVANCING THE CONCERTO COIL THROUGH THE MICROCATHETER, THE COIL WAS DEPLOYED IN THE MICROCATHETER WITHOUT ANY MECHANICAL DETACHMENT. IT WAS NOTED THERE WAS FRICTION/DIFFICULTY DURING DELIVERY AND THE PROXIMAL SEGMENT OF THE PUSHWIRE BROKE RESULTING IN THE PREMATURE DETACHMENT OF THE COIL IN THE MICROCATHETER. THE PHYSICIAN DID NOT REPOSITION THE COIL, ATTEMPT TO DETACH THE COIL, OR ROTATE THE PUSHER DURING DELIVERY. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, AND NO SURGICAL/MEDICAL INTERVENTION WAS REQUIRED. THE MICROCATHETER WAS REMOVED FROM THE PATIENT WITH THE COIL. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9684044 ↗
• InjurySep 10, 2019Difficult or Delayed Positioning; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Migration; Difficult or Delayed Positioning; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT FIT PERFECTLY, SOT HE PHYSICIAN PULLED IT BACK IN ORDER TO TAKE IT OUT OF THE MICROCATHETER. HOWEVER, IN DOING SO THEY DID NOT NOTICE THAT THE COIL DID NOT COME ALL THE WAY OUT OF THE MICROCATHETER AND DETACHED INSIDE WITHOUT THE STAFF KNOWING. DURING A QUICK SYRINGE INJECTION TO CHECK THE POSITION OF THE CATHETER, THE COIL WAS FLUSHED FORWARD AND AUTO DEPLOYED ACCIDENTALLY IN THE WRONG POSITION WITHIN THE ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE VIA SNARE BUT COULD NOT, SO THEY DECIDED TO LEAVE IT INSIDE THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY FOR EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY, AN OFF-LABEL USE. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THE PUSHWIRE WAS NOT BENT OR BROKEN, THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, NO ATTEMPTS WERE MADE TO REPOSITION OR DETACH THE COIL. A CONTINUOUS FLUSH WAS NOT USED DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8983995 ↗
• MalfunctionApr 14, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF CONCERTO RESISTANCE IN A CATHETER DURING A PROCEDURE. THE CONCERTO WAS NOT IMPLANTED IN THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICES HAD BEEN PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSHED WAS NOT USED DURING THE PROCEDURE. THE CONCERTO WAS RETURNED AND THE PUSHWIRE WAS OBSERVED TO BE SEPARATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8512647 ↗
• MalfunctionJan 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT OF EMBOLIZATION, THIS COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER DURING ADVANCE. THERE WAS NOT ANY FRICTION OR DIFFICULTIES DURING DELIVERY. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. YES, THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THERE WAS NO KINK/DAMAGE TO THE PUSHWIRE. PROGREAT MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219173 ↗