ConcertoTM PV-12-30-HELIX (UDI 00847536016941)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536016941), received between Mar 20, 2017 and Oct 7, 2019 — classified as 5 malfunctions.

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

• MalfunctionOct 7, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT THIS COIL BROKE DURING THE PROCEDURE. THE IMPLANT COIL REMAINS IN THE PATIENT. DEVICE OR DEVICE FRAGMENTS REMAIN IN PATIENT. RESISTANCE FELT WHEN THE DEVICE BROKE. THE PATIENT WAS UNDERGOING COILING TREATMENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO PATIENT INJURY WAS REPORTED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9162215 ↗
• MalfunctionMay 30, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING A COILING EMBOLIZATION OF SPLENIC ANEURYSM, THREE CONCERTO COILS FAILED TO BE DETACHED WITH INSTANT DETACHERS. THERE WAS NO ALLEGATION OF A PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8655695 ↗
• MalfunctionMar 25, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL WAS PREPARED PER THE INSTRUCTIONS FOR USED BUT WAS UNABLE TO BE USED AS IT WAS STRETCHED OUT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO PATIENT INJURY OCCURRED. THE CUSTOMER WAS NOTIFIED TO RETURN THE DEVICE. THE DEVICE WAS REPORTED TO HAVE BEEN PREPARED AND USED PER THE INSTRUCTIONS FOR USE. NO ADDITIONAL INFORMATION IS AVAILABLE (LEGAL/CONFIDENTIAL REASON).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8448065 ↗
• MalfunctionFeb 15, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT A CONCERTO COIL WAS UNABLE TO DETACHED DURING A PROCEDURE. THE COIL WAS ABLE TO BE DELIVERED THROUGH THE CATHETER; THE CATHETER WAS FLUSHED. THE COIL WAS REPORTED TO HAVE BEEN ATTEMPTED TO BE DETACHED VIA MANUAL DETACHMENT ONLY ONCE. THERE WAS NO INSTANT DETACHER USED. UPON REMOVAL OF THE CATHETER, IT WAS REALIZED THAT THE COIL DID NOT DETACH. THESE DEVICES WERE REMOVED, ASSESSED AND PHOTOGRAPHED. THE DEVICES WERE THEN DISCARDED AT THE SITE. COMPETITOR DEVICES WERE USED TO TREAT THE PATIENT. THE PATIENT'S ANATOMY AND THE BLOOD FLOW WERE BOTH NORMAL. THE ACCESS VESSEL WAS THE HIPOGASTRICA (VESSEL DIAMETER WAS 10MM). THE DEVICES WERE REPORTED TO HAVE BEEN PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS STATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344665 ↗
• MalfunctionMar 20, 2017Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT OF DISTAL GONADAL VEIN, THIS COIL WOULD NOT DETACH WITH MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE). THE PHYSICIAN TRIED 3-4 TIMES WITH MANUAL METHOD BUT STILL COIL DID NOT DETACH. IT WAS REPORTED THAT PHYSICIAN DID NOT USE INSTANT DETACHER TO DETACH THE COIL. ANOTHER COIL WAS USED AND PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6417666 ↗