V-Trak 7110-0619-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777023704), received between Feb 24, 2022 and Aug 27, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 16, 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.

• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RAGE CLINICAL TRIAL, THE PATIENT HAD RECURRENCE OF ANEURYSM DISCOVERED DURING ROUTINE FOLLOW-UP SEVEN MONTHS POST PROCEDURE. THE ANEURYSM RECURRENCE WAS TREATED 270 DAYS POST IMPLANTATION USING AN ANEURYSM FLOW DIVERTER DEVICE AND THE ISSUE WAS CONFIRMED RESOLVED WITHOUT SEQUELAE ON FOLLOW-UP. THE ADVERSE EVENT WAS ASSESSED AS PROBABLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE STUDY PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 20076464 ↗
• MalfunctionMar 6, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WAS MISSING FROM ITS DELIVERY PUSHER; THE DEVICE WAS BEING ADVANCED IN THE MICROCATHETER WHERE THE IMPLANT WAS NOTICED TO BE MISSING UNDER FLUOROSCOPY. THE COIL WAS NOT PRESENT IN THE MICROCATHETER OR PACKAGING HOOP OR STERILE FIELD. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO INJURY OR INTERVENTION. IT WAS REPORTED THAT THERE WERE ¿NO PATIENT CARE SEQUELAE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852906 ↗
• InjuryMay 1, 2023Device Dislodged or Dislocated; Premature Separation; Device Dislodged or Dislocated; Premature Separation

  SEE H10.

  Patient problems: Ruptured Aneurysm

  MAUDE report 16842388 ↗
• MalfunctionFeb 24, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, THE COIL WAS ADVANCED WITHIN THE MICROCATHETER. THE MICROCATHETER LOST ACCESS TO THE ANEURYSM. IT WAS DECIDED TO RE-SHEATH THE COIL. UPON WITHDRAW IT WAS OBSERVED THAT THE COIL WAS NOT MOVING VIA FLUOROSCOPY. THE PUSHER WAS REMOVED AND THE COIL WAS OBSERVED TO HAVE PREMATURELY DETACHED FROM THE DELIVERY PUSHER. A SYRINGE WAS ATTACHED TO THE MICROCATHETER AND ASPIRATED AS THE COIL AND CATHETER WERE REMOVED TOGETHER. THE COIL WAS REMOVED FROM THE CATHETER OUTSIDE THE PATIENT AND IT WAS OBSERVED TO BE STRETCHED. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592545 ↗