ConcertoTM PV-18-40-3D (UDI 00847536026520)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536026520), received between Mar 5, 2019 and Oct 30, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THIS COIL DETACHED PREMATURELY DURING PREPARATION, OUTSIDE THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9256899 ↗
• 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 8655614 ↗
• 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 8655601 ↗
• MalfunctionMar 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT DURING A COILING PROCEDURE, THE CONCERTO COIL WAS REPORTED TO HAVE UNINTENTIONALLY DETACHED WHEN BEING INSERTED INTO THE ANEURYSM. THE COIL WAS RETRIEVED WITH A SNARE DEVICE. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL COILS. NO PATIENT INJURY OCCURRED. THE DEVICES WERE REPORTED TO HAVE BEEN PREPARED AND USED PER THE INSTRUCTIONS FOR USE. THE VESSEL ANATOMY WAS SEVERE. THE COIL WAS NOT REPOSITIONED. IT IS UNKNOWN IF THE PUSHWIRE WAS ROTATED DURING THE ADVANCEMENT. A CONTINUOUS FLUSH WAS NOT MAINTAINED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8391273 ↗