V-Trak 100306HS-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816777024114), received between Oct 25, 2018 and Jul 1, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Component Missing

  IT WAS REPORTED THAT THE CONCERNED EMBOLIZATION COIL WAS BEING USED IN CONJUNCTION WITH A COIL-ASSIST STENT TO TREAT A PATIENT WITH A LEFT PCOM ANEURYSM USING "JAILING" TECHNIQUE. AFTER PLACING THE STENT (REF. MFR REPORT#: 2032493-2026-08049), THE PHYSICIAN STARTED COILING THE ANEURYSM WITH THE CONCERNED COIL AND REPORTEDLY NOTED THAT THE 3CM PROXIMAL RADIOPAQUE MARKER WAS MISSING FROM THE COIL. THE PHYSICIAN USED FLUOROSCOPY TO ASSESS WHETHER THE COIL WAS INSIDE THE ANEURYSMAL SAC IN ORDER TO DETACH IT, AS THIS CAN BE MISLEADING AT CERTAIN ANGLES. THE PHYSICIAN COULD SEE WHEN THE COIL WAS ON THE TIP OF THE MICROCATHETER FOR THE DETACHMENT ZONE. THE COIL WAS DETACHED AND IMPLANTED IN THE ANEURYSM. THE PATIENT WAS DOING VERY WELL AFTER THE PROCEDURE AND WAS ABLE TO MOVE BOTH ARMS AND LEGS; AND ABLE TO ANSWER USUAL QUESTIONS. THIS IS EVENT REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681827 ↗
• MalfunctionJun 23, 2026Component Missing

  AS REPORTED: WHEN THE COIL WAS REMOVED FROM THE MICROCATHETER, DR. NOTICED THAT THERE WAS NO RADIOPAQUE MARKING ON THE PROXIMAL END OF THE COIL. THE COIL WAS REMOVED AS A PRECAUTION BUT WAS DISPOSED OF DIRECTLY IN THE WASTE BIN. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591473 ↗
• InjuryJan 11, 2022Stretched; Stretched

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE PUSHER OF AN EMBOLIZATION COIL IMPLANT STRETCHED DURING POSITIONING. A STENT WAS USED TO AFFIX THE PUSHER TO THE VESSEL WALL BUT THE STRETCHED PORTION EXTENDED INTO THE CAROTID ARTERY. A STENT WAS USED TO REMOVE THE REMAINING PORTION OF THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13232794 ↗
• MalfunctionAug 18, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT KEPT COMING OUT OF THE ANEURYSM NECK DURING PLACEMENT. THE COIL WAS REMOVED FROM THE PATIENT WHERE IT WAS OBSERVED THAT THE COIL WAS THE INCORRECT SIZE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340476 ↗
• InjuryOct 25, 2018Stretched; Stretched

  IT WAS REPORTED THAT DURING REPOSITIONING OF THE EMBOLIZATION COIL IN AN ANEURYSM, THE COIL STRETCHED AND THEN COULD NOT BE WITHDRAWN INTO THE MICROCATHETER. THE COIL WAS PUSHED FORWARD UNTIL IT WAS FULLY WITHIN THE ANEURYSM AND WAS THEN INTENTIONALLY DETACHED MANUALLY WTIHOUT THE CONTROLLER. FOLLOW-UP ANGIOGRAPHY DEMONSTRATED THROMBUS AT THE NECK OF THE ANEURYSM AND IN THE VESSEL. IV INTEGRILIN WAS ADMINISTERED AS TREATMENT. THE PATIENT WAS REPORTED TO BE ALRIGHT AND HAD A GOOD OUTCOME.

  Patient problems: Thrombus

  MAUDE report 8007117 ↗