V-Trak 7110-0408-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816777023667), received between Feb 9, 2018 and Jul 11, 2025 — classified as 1 death, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Separation Failure; Separation Problem; Separation Failure; Separation Problem

  AS REPORTED, THE DETACHER WOULD GIVE A GREEN LIGHT UPON TESTING INDICATING A GOOD CONNECTION BUT THEN WHEN THE BUTTON WAS DEPRESSED, ONLY A SINGLE BEEP WAS HEARD. THIS HAPPENED MULTIPLE TIMES EVEN AFTER WIPING THE PUSHER DOWN WITH GAUZE. DURING MANIPULATION OF THE COIL, IT RUPTURED THROUGH THE ANEURYSM. THE PHYSICIAN WAS ABLE TO GET THE COIL DETACHED AND QUICKLY INTRODUCE ANOTHER COIL TO STOP THE BLEEDING. THE PATIENT WAS UNHARMED. ADDITIONAL INFORMATION INDICATED THAT THE DETACHMENT DIFFICULTY REQUIRING MANIPULATION OF THE FIRST COIL RUPTURED THE ANEURYSM.

  Patient problems: Ruptured Aneurysm

  MAUDE report 22487765 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE RAGE STUDY A MILD COIL COMPACTION AND RECURRENCE AT THE BASE OF THE RUPTURED ANEURYSM. THE PATIENT UNDERWENT RETREATMENT WITH COILING. THE PATIENT HAD A RUPTURED ANEURYSM PRIOR TO THE INDEX PROCEDURE. REASON FOR RETREATMENT WAS NOTED TO BE MILD COIL COMPACTION AND RECURRENCE AT THE BASE OF THE RUPTURED (INDEX) ANEURYSM. INDEX PROCEDURE DATE: (B)(6)2021. ANEURYSM LOCATION: ANTERIOR COMMUNICATING ARTERY. ANEURYSM SIDE: MIDLINE. HEIGHT: 5.3MM. WIDTH: 3.4MM. DEPTH: 3.2MM. NECK SIZE: 1.2MM. DONE TO NECK RATIO: 2.83MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645862 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A RAGE CLINICAL STUDY, THE PATIENT HAD AN ANEURYSM RECANALIZATION OBSERVED THROUGH MRI IMAGING POST-OPERATIVE. THIS EVENT WAS TREATED WITH A FLOW-DIVERTING STENT. THE PATIENT¿S OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

  Patient problems: Aneurysm

  MAUDE report 19356237 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED FROM THE RAGE CLINICAL STUDY, EVENT TERM : THROMBOEMBOLIC EVENT, PERFUSION DEFICIT OBSERVED. EVENT #: 4, POST OPERATIVE DAYS: 0 DAYS. IT WAS REPORTED THAT DURING PROCEDURE. DECISION WAS MADE TO ATTEMPT THROMBOASPIRATION WITHIN THE LEFT A1-A2. A 3 MAX CATHETER WAS THEN ADVANCED OVER THE SYNCHRO WIRE AND ADVANCED INTO THE ANTERIOR COMMUNICATING COMPLEX. ANGIOGRAPHY THROUGH THE 3 MAX CATHETER AT THE LEVEL OF THE ANTERIOR COMMUNICATING ARTERY COMPLEX WAS PERFORMED DEMONSTRATING GOOD FILLING OF THE RIGHT A2 BRANCH AND SLUGGISH FLOW WITHIN THE LEFT A2. AT THIS TIME THE PATIENT HAD A BRIEF EPISODE OF HYPERTENSION, AND WHOLE HEAD ANGIOGRAPHY WAS REPEATED, SHOWING NO EVIDENCE OF EXTRAVASATION OR ANEURYSM RUPTURE AND IMPROVED FLOW WITHIN THE LEFT A1 AND A2 BRANCHES. DUE TO IMPROVED FLOW TO THE LEFT ACA, NO FURTHER ATTEMPTS TO ACCESS THE LEFT DISTAL ACA WAS PERFORMED. THE EVENT WAS INDICATED TO PROBABLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE STUDY PROCEDURE. AE OUTCOME: RESOLVED WITHOUT SEQUELAE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 18636072 ↗
• MalfunctionJan 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A RUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE EMBOLIZATION COIL DETACHED. THE COIL REMAINS IMPLANTED. NO ADDITIONAL INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY OR SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11255496 ↗
• DeathFeb 9, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL WAS ADVANCED INTO THE ANEURYSM, TESTED, AND DETACHED. WHEN THE PUSHER WIRE WAS RETRACTED, THE DISTAL END REMAINED INSIDE OF THE MICROCATHETER. THE MICROCATHETER WAS RETRACTED WHILE PULLING THE DISTAL END AWAY FROM THE ANEURYSM AND A PORTION OF THE COIL INTO THE PARENT ARTERY. THE PUSHER WIRE FRAGMENT FELL OUT OF THE MICROCATHETER, AND WAS SUCCESSFULLY RETRIEVED WITH A SNARE DEVICE. THE COIL WAS RETRACTED INTO THE MICROCATHETER BY MEANS OF INFLATING A BALLOON AT THE TIP, AND REMOVING THE BALLOON ALONG WITH THE MICROCATHETER. A HEMORRHAGE WAS NOTED ON AN ANGIOGRAM. A BALLOON WAS INFLATED TO STOP THE HEMORRHAGE PRIOR TO THE PLACEMENT AND REMOVAL OF A VENTRICULOSTOMY DRAIN. PROTAMINE WAS ADMINISTERED, AND A NICARDIPINE INFUSION WAS STARTED. THE PATIENT DIED THE DAY AFTER THE PROCEDURE. THE CAUSE OF THE DEATH IS UNKNOWN.

  Patient problems: Death; Hemorrhage, Cerebral

  MAUDE report 7259809 ↗