V-Trak 7110-0612-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777023698), received between Oct 26, 2021 and Oct 11, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RAGE CLINICAL STUDY, EVENT TERM: ANEURYSM RECANALIZATION EVENT WAS REVIEWED BY INDEPENDENT REVIEWER (CEA) AND WAS DETERMINED TO BE DEFINITELY RELATED TO STUDY DEVICE AND POSSIBLY RELATED TO STUDY PROCEDURE. SUBJECT #(B)(6). EVENT #: 5. EVENT START DATE: 24/MAR/2020. POST OPERATIVE DAYS: 57 DAYS. EVENT DESCRIPTION: RECANALIZATION OF ANEURYSM NOTED ON FOLLOW UP MRI IMAGING. DSA COMPLETED TO ASSESS AND THEN ANEURYSM RETREATED. FOLLOW UP IMAGING SHOWED IMPROVEMENT AND RESOLUTION. AE OUTCOME: RESOLVED WITHOUT SEQUELAE. DEVICES INVOLVED: HYDROFRAME LOT: 1810205WF. HYDROFRAME LOT: 1810025WF. HYDROSOFT 3D LOT: 1909041W6. AS IT CANNOT BE DETERMINED WHICH COIL DEVICE MAY HAVE IMPACTED THE EVENT, HYDROFRAME 6X12, LOT 1810205WF WAS CHOSEN AS A DEFAULT PRIMARY DEVICE. THE OTHER COILS USED IN THE PROCEDURE WILL BE LISTED AS CONCOMITANT DEVICES.

  Patient problems: Aneurysm

  MAUDE report 20425076 ↗
• InjuryMar 24, 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 THE PATIENT HAD A CEREBRAL ANGIOGRAM WITH ENDOVASCULAR COILING OF ANEURYSM ON (B)(6) 2021. DURING THE PROCEDURE A PARTIALLY OCCLUSIVE MIDDLE CEREBRAL ARTERY THROMBUS WAS IDENTIFIED AND SYRINGE ASPIRATION WAS PERFORMED. POST PROCEDURE IMAGING SHOWED THE THROMBUS WITHIN THE DISTAL POSTERIOR M2 BRANCH OF THE MIDDLE CEREBRAL ARTERY WAS RESOLVED AND ALL BRANCHES WERE PATENT. THE PATIENT OUTCOME WAS RESOLVED WITHOUT SEQUELAE. AN INDEPENDENT REVIEWER DEEMED THE THROMBUS TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLY RELATED TO STUDY PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18966403 ↗
• MalfunctionOct 26, 2021Detachment of Device or Device Component; Difficult or Delayed Separation; Detachment of Device or Device Component; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING TREATMENT OF A RECURRENT BASILAR TIP ANEURYSM BY COIL EMBOLIZATION, AN EMBOLIZATION COIL IMPLANT WAS PLACED IN THE ANEURYSM BUT WOULD NOT DETACH. THE PHYSICIAN DECIDED TO REMOVE THE COIL AND THE IMPLANT UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE DELIVERY PUSHER WAS USED TO PUSH THE IMPLANT INTO THE ANEURYSM. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. IT WAS REPORTED THAT THE PATIENT WAS SUCCESSFULLY TREATED WITHOUT SEQUELAE AND WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698766 ↗