V-Trak 100206HS-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816777020628), received between Oct 18, 2017 and Oct 30, 2020 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A PCOM ANEURYSM, THE EMBOLIZATION COIL UNEXPECTEDLY DETACHED FROM THE DELIVERY SYSTEM. THE DETACHED IMPLANT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH A STENT RETRIEVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10760129 ↗
• MalfunctionJul 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A LEFT INTERNAL CAROTID ARTERY ANEURYSM, THE IMPLANT COIL DETACHED WHILE BEING REPOSITIONED IN THE ANEURYSM. THE DETACHED IMPLANT WAS PUSHED INTO THE ANEURYSM IN ITS ENTIRETY USING THE DELIVERY PUSHER OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8801046 ↗
• MalfunctionApr 4, 2019Stretched; Detachment of Device or Device Component; Device-Device Incompatibility; Stretched; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE TREATMENT OF A LEFT SIDE SUPERFICIAL PARA-AURICULAR ARTERIOVENOUS MALFORMATION, THE COIL DETACHED SUCCESSFULLY; HOWEVER, DURING REMOVAL OF THE PUSHER, FRICTION WAS ENCOUNTERED. THE PUSHER WIRE STRETCHED AND THEN BROKE IN THE MICROCATHETER. THE ENTIRE PUSHER WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8484527 ↗
• MalfunctionNov 21, 2018Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON AN ANTERIOR COMMUNICATION ARTERY ANEURYSM FIVE (5) DAYS AFTER THE PATIENT HAD A SUBARACHNOID HEMORRHAGE AND VASOSPASM. DURING PLACEMENT OF THE FOURTH COIL, THE COIL STRETCHED AND THEN DETACHED IN THE MICROCATHETER WITHOUT USE OF THE CONTROLLER. THERE WAS NO ADDITIONAL INTERVENTION AND THE COIL WAS LEFT IN POSITION IN THE ANEURYSM. A TOTAL OF 16 COILS WERE PLACED IN THE ANEURYSM. TWO (2) DAYS AFTER THE PROCEDURE, THE PATIENT WAS TREATED FOR VASOSPASM WITH A COMBINATION OF PHARMACOLOGICAL AND ANGIOPLASTY, AND HAS HAD THREE (3) SUBSEQUENT VASOSPASM TREATMENTS SINCE. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE COIL DETACHMENT. THE PATIENT IS REPORTED TO BE "NOT IN GREAT CONDITION FOLLOWING THE SAH AND DELAYED TREATMENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8097886 ↗
• InjuryApr 19, 2018Detachment Of Device Component; Difficult To Position; Detachment Of Device Component; Difficult To Position

  IT WAS REPORTED THAT DURING THE PLACEMENT OF THE LAST EMBOLIZATION COIL IN A GIANT SACCULAR ANEURYSM, THE COIL "MOVED" PARTIALLY INSIDE THE STENT. DURING A WITHDRAWAL ATTEMPT, THE COIL DETACHED PARTIALLY INSIDE THE STENT. THROMBUS WAS NOTED INSIDE THE STENT, WHICH WAS TREATED SUCCESSFULLY WITH AGGRASTAT. THE PATIENT'S CURRENT STATUS IS REPORTED TO BE STABLE.

  Patient problems: Thrombus

  MAUDE report 7443471 ↗
• InjuryNov 9, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT SEVERAL ATTEMPTS WERE MADE TO DETACH AN EMBOLIZATION COIL; HOWEVER, THE COIL DID NOT DETACH. DURING REMOVAL, THE COIL UNEXPECTEDLY DETACHED, LEAVING SOME OF THE IMPLANTED COIL IN THE PARENT ARTERY. THE PHYSICIAN CHOSE TO OCCLUDE THE CAROTID ARTERY, WHICH RESULTED IN OCCLUSION OF THE ANTERIOR COMMUNICATING ARTERY AND TWO (2) A2 ARTERIES. REOPRO AND HEPARIN WERE ADMINISTERED. A SUBARACHNOID HEMORRHAGE OCCURRED DURING THE NIGHT, AND AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS PERFORMED. THE PATIENT IS REPORTED TO HAVE NO NEUROLOGICAL DEFICIT.

  Patient problems: Hemorrhage, Subarachnoid; Occlusion

  MAUDE report 7016469 ↗
• InjuryOct 18, 2017Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  IT WAS REPORTED THAT AFTER PLACEMENT OF THE FINAL EMBOLIZATION COIL IN AN A-COM ANEURYSM, THE COIL DID NOT DETACH. DURING REMOVAL, THE COIL UNEXPECTEDLY DETACHED. THE COIL WAS SUCCESSFULLY RETRIEVED WITH A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6960387 ↗