V-Trak 7110-0306-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00816777025463), received between Dec 14, 2017 and Nov 6, 2025 — classified as 1 death, 5 injuries, 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Premature Separation; Premature Separation

  AS REPORTED: DURING A COILING PROCEDURE FOR TREATMENT OF LMCA ANEURYSM, THE 2ND COIL PREMATURELY DETACHED IN HEADWAY DUO MICROCATHETER WHILE HE WAS PUSHING IT IN. THE PHYSICIAN REMOVED BOTH THE MICROCATHETER AND THE COIL THAT WAS INSIDE. OPENED ANOTHER COIL AND HEADWAY DUO AND PROCEEDED TO FINISH THE EMBOLIZATION. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION PERFORMED. THERE WAS NO PATIENT IMPACT OR INJURY, THE PATIENT IS STABLE. DEVICES IN QUESTION WERE DISCARDED. NO OTHER INCIDENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490610 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RAGE CLINICAL STUDY THAT A RUPTURED RIGHT M2 SACCULAR ANEURYSM WAS TREATED WITH AN EMBOLIZATION IMPLANT COIL. WHEN THE PATIENT RETURNED TO THE NSICU, THEY WERE FOUND TO HAVE NEW ONSET LEFT HEMIPLEGIA AND GAZE PREFERENCE. AN URGENT NCCT DID NOT SHOW RE-BLEEDING. PATIENT SENT FOR DSA TO ASSESS LARGE VESSEL OCCLUSION. MECHANICAL THROMBECTOMY WAS THEN PERFORMED ON THROMBUS AT R PROXIMAL M2. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

  Patient problems: Paralysis; Thrombosis/Thrombus; Visual Impairment

  MAUDE report 19379063 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, EVENT DESCRIPTION : THE PATIENT INITIALLY PRESENTED WITH HYDROCEPHALUS ON (B)(6), 2021, AND AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS INSERTED FOR TREATMENT. SUBSEQUENT IMAGING SHOWED VARYING DEGREES OF IMPROVEMENT AND WORSENING OF VENTRICULAR CALIBER AND HYDROCEPHALUS. DESPITE ATTEMPTS WITH LUMBAR DRAINS AND SHUNT INSERTIONS, THE PATIENT EXPERIENCED RECURRENT HYDROCEPHALUS AND COMPLICATIONS INCLUDING INFECTION AND ENTRAPMENT OF THE FOURTH VENTRICLE. MULTIPLE PROCEDURES WERE PERFORMED TO MANAGE THE CONDITION, INCLUDING SHUNT REVISIONS AND ENDOSCOPIC INTERVENTIONS. IMAGING OVER THE COURSE OF SEVERAL WEEKS SHOWED FLUCTUATIONS IN VENTRICULAR SIZE AND IMPROVEMENT IN HYDROCEPHALUS FOLLOWING INTERVENTIONS. MRI (B)(6) 2021 NO SIGNS OF HYDROCEPHALUS OR MIDLINE SHIFT. CT (B)(6) 2021 NO EVIDENCE OF HYDROCEPHALUS. AE OUTCOME : RESOLVED WITHOUT SEQUELAE. THE HYDROCEPHALUS WAS REVIEWED BY CEA AND DETERMINED TO BE POSSIBLY RELATED TO THE STUDY DEVICE. THE INITIAL COIL EMBOLIZATION TREATMENT, MIDLINE ANTERIOR COMMUNICATING ARTERY RUPTURED ANEURYSM ON (B)(6) 2021. THE PATIENT INITIALLY PRESENTED WITH HYDROCEPHALUS PRIOR TO PROCEDURE. HOWEVER, POST PROCEDURE, THE HYDROCEPHALUS WORSENED.

  Patient problems: Hydrocephalus; Unspecified Infection

  MAUDE report 19327200 ↗
• DeathMay 1, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT A PATIENT ENROLLED IN THE RAGE STUDY PRESENTED TO THE HOSPITAL AFTER LOSING CONSCIOUSNESS AND STRIKING THE BACK OF THEIR HEAD. ACCORDING TO MEDICAL RECORDS, UPON ARRIVING AT THE HOSPITAL, EXTENSIVE SUBARACHNOID HEMORRHAGE AND INTRAVENTRICULAR INTRACRANIAL HEMORRHAGE WAS OBSERVED THROUGH CT. THE NEXT DAY, ANGIOGRAM REVEALED AN ACOM ANEURYSM, WHICH THE PHYSICIAN TREATED WITH EMBOLIZATION IMPLANT COILS. AS DESCRIBED ON THE OPERATIVE REPORT DATED (B)(6) 2019 , DURING THE PROCEDURE, THE MICROCATHETER LOST POSITION WHEN THE FIRST EMBOLIZATION COIL IMPLANT WAS BEING PLACED. IT WAS REPORTED THAT THE MICROCATHETER COULD NOT REGAIN ACCESS AND THE FIRST COIL WAS WITHDRAWN, AFTER WHICH EXTRAVASATION WAS OBSERVED. A BALLOON CATHETER WAS INFLATED FOR THREE MINUTES BUT WAS THEN DEFLATED WHEN EXTRAVASATION DID NOT IMPROVE. FOUR COIL IMPLANTS WERE THEN REPORTEDLY PLACED IN THE ANEURYSM WITH NO FURTHER EVIDENCE OF EXTRAVASATION. THE MEDICAL RECORDS FURTHER PROVIDE THAT THE PHYSICIAN THEN PLACED AN EXTERNAL VENTRICULAR DRAIN THE SAME DAY. THE PATIENT WAS REPORTEDLY TAKEN BACK TO THE CATHETER LAB 2 DAYS POST PROCEDURE FOR AN ANGIOGRAM, WHICH SHOWED A STABLE ACOM COIL MASS WITH NO

  Patient problems: Extravasation

  MAUDE report 19226784 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE RAGE CLINICAL STUDY: THE PATIENT COMPLETED A ROUTINE DIAGNOSTIC ANGIOGRAM 185 DAYS POST-OP AND A RECURRENCE OF THE ANEURYSM WAS SEEN. THE PATIENT WAS THEN SCHEDULED FOR A CRANIOTOMY DUE TO HIS RISK OF A RUPTURE. ADVERSE EVENT OUTCOME : RESOLVED WITHOUT SEQUELAE. THE INDEPENDENT REVIEWER DETERMINED THE EVENT TO BE RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE STUDY PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 19093874 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE H10.

  Patient problems: Aneurysm

  MAUDE report 18992461 ↗
• InjuryMar 31, 2021Migration; Migration

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A RUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM, AN EMBOLIZATION COIL IMPLANT HAD A COIL TAIL EXTEND INTO THE PARENT ARTERY. IT THEN MIGRATED FURTHER INTO THE PROXIMAL LEFT MIDDLE CEREBRAL ARTERY (MCA). INTEGRILIN WAS GIVEN AS A INTRAVENOUS BOLUS, FOLLOWED BY INFUSION. AN INTRACRANIAL STENT WAS DEPLOYED FROM THE PROXIMAL LEFT MCA INTO THE LEFT INTERNAL CAROTID ARTERY, TACKING DOWN THE MIGRATED COIL LOOP AND CROSSING THE NECK OF THE ANEURYSM. CHECK ANGIOGRAPHY SHOWED APPROPRIATE PLACEMENT OF THE STENT, AND LACK OF THROMBOEMBOLIC COMPLICATIONS OR PLATELET AGGREGATES. THE PATIENT IS REPORTEDLY "DOING WELL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600581 ↗
• MalfunctionDec 14, 2017Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  IT WAS REPORTED THAT SEVERAL ATTEMPTS WERE MADE TO DETACH THE COIL; HOWEVER, THE COIL DID NOT DETACH. DURING REMOVAL, THE COIL UNEXPECTEDLY DETACHED. THE COIL WAS THEN ADVANCED INTO THE INTENDED TREATMENT SITE WITH THE PUSHER WIRE. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7119526 ↗