ConcertoTM NV-4-10-HELIX (UDI 00847536013414)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536013414), received between Dec 13, 2018 and Apr 30, 2020 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 UNDER X-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 10014623 ↗
• MalfunctionSep 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PROCEDURE COULD NOT BE PERFORMED BECAUSE THE COIL DID NOT ENTER THE MICROCATHETER WHILE PERFORMING THE PROCEDURE IN ACCORDANCE WITH THE IFU. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9130352 ↗
• InjurySep 25, 2019Migration; Migration

  MEDTRONIC RECEIVED REPORT THAT THE 2 CONCERTO COIL MIGRATED AND REQUIRED INTERVENTION. DURING THE COMPLETING OF AN EMBOLIZATION OF A VARICOCELE. THE VARICOCELE WAS TREATED WITH A COMBINATION OF COILS AND SCLEROSANT. A CONCERTO 4 X 10 WAS PLACED, FOLLOWED BY 7 X 30, INJECTED SCLEROSANT THEN WENT TO CAP THE TOP OF THE GONADAL BELOW THE RENAL ORIGIN WITH A 7 X 30 AND EMBEDDED A 4 X 10 TO CREATE A DENSE PACK AT THE TOP. THE INITIAL VISUAL RESULT LOOKED GOOD. A SLIGHT PUFF OF CONTRAST WAS PERFORMED AND LOOKED GOOD. THE CATHETER WAS BACK TO DO A MORE POWERFUL INJECTION AS A FINAL RUN. UPON INJECTING, THE LAST 2 COILS SHOT UP AND OUT OF THE GONADAL VEIN FLOWING INTO THE RENAL VEIN. THE 4 X 10 COIL SAT AT THE RENAL ORIGIN OFF OF THE INFERIOR VENA CAVA (IVC) FOR A MOMENT AND THEN SHOT UP TO THE LUNGS. THE 7 X 30 WAS STRUNG OUT AND HANGING HALF IN THE GONADAL AND HALF IN THE RENAL. THE CONCERTO COIL 7 X 30 WAS SNARED OUT QUICKLY. ATTEMPTS WERE MADE TO SNARE THE 4 X 10 CONCERTO COIL OUT OF THE LUNG. AN HOUR PLUS WITHOUT SUCCESS. THE VARICOCELE EMBOLIZATION WAS THEN COMPLETED WITH 7 X 30 (A541620). THEN ATTEMPTS TO REMOVE THE 4 X 10 COIL FROM THE LUNG WERE RESUMED. VARIETY OF TECHNIQUES WERE U

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9119444 ↗
• MalfunctionJun 28, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DETACH FROM THE MICROCATHETER. HOWEVER, AFTER REPLACING THE COIL, THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE ANATOMY WAS REPORTED TO HAVE BEEN NORMAL. 2 TO 3 DETACH ATTEMPTS WERE MADE THE INSTANT DETACHER AND 2 TO 3 DETACHMENTS WERE MADE VIA THE MANUAL METHOD. ISSUES OCCURRED PRIOR TO THE DETACHMENT ATTEMPTS. NO DAMAGE WAS NOTED ON THE REMOVED PUSHWIRE. THE DEVICES WERE PREPARED AND USED PER THE IFU. ANCILLARY DEVICES INCLUDE A PROGREAT MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745772 ↗
• MalfunctionApr 4, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING A POPLITEAL ARTERY PROCEDURE, THE COIL WAS PUSHED OUT THROUGH THE MICROCATHETER, AND WHEN IT WAS TIME TO DETACH THE COIL, IT WOULD NOT. THEY REMOVED THE COIL AND PROCEEDED WITH ANOTHER. IT WAS STATED THAT THE PHYSICIAN ATTEMPTED 2-3 TIMES TO DETACH THE COIL WITH THE INSTANT DETACHER. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484641 ↗
• MalfunctionDec 13, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT 2 AXIUM PRIME COILS AND 1 CONCERTO COIL FAILED TO DETACH. IT WAS REPORTED THAT UPON DELIVERY OF THE COIL, DETACHMENT WAS ATTEMPTED USING THE INSTANT DETACHER (ID), BUT THE COIL DID NOT DETACH. THEN DETACHMENT WAS ATTEMPTED WITH THE HYPOTUBE BREAK METHOD, BUT THE COIL DID NOT DETACH. 2 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER AND ONE ATTEMPT WAS MADE VIA THE SECOND DETACHMENT METHOD. THE PUSHWIRE WAS SEATED DEEP INTO THE ID WHEN THE DETACHMENT ATTEMPTS WERE MADE.THE DEVICES WERE RETRIEVED AND REMOVED FROM THE ANATOMY. THE COILS WERE REPORTED TO HAVE BEEN PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED, AND COILS WERE HYDRATED PER THE IFU. CONTINUOUS FLUSH WAS NOT USED DURING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED TO HAVE OCCURRED. THE ID AND THE COILS WILL BE RETURNED FOR ANALYSIS. NO ISSUES WERE REPORTED WITH THE ID. THE ANATOMY WAS MODERATE IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161326 ↗