V-Trak 7110-0515-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00816777023681), received between Feb 13, 2019 and May 21, 2026 — classified as 1 death, 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 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.

• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CAR REGISTRY STUDY THAT AN M1-M2 ARTERY OCCLUSION OCCURRED. ANOTHER COIL WAS PLACED INTO THE RIGHT MCA M2 ANEURYSM. PRIOR TO DEPLOYING, A RIGHT INTERNAL CAROTID ARTERY ARTERIOGRAM WAS PERFORMED, WHICH DEMONSTRATED OCCLUSION OF THE STENTED RIGHT M1-M2 BRANCH. AT THIS POINT, THE COIL WAS EXPLANTED. THE PATIENT WAS ADMINISTERED A 90 MCG/KG BOLUS OF INTEGRILIN. AN ATTEMPT WAS MADE TO RE-ACCESS THE STENT USING A MICROCATHETER AND MICROWIRE, BUT THIS WAS UNSUCCESSFUL. A REPEAT RIGHT INTERNAL CAROTID ARTERY ARTERIOGRAM, WAS PERFORMED 7-8 MINUTES AFTER INTEGRILIN BOLUS, DEMONSTRATED REPERFUSION OF THE STENTED RIGHT M1-M2 BRANCH, AND THIS WAS CONFIRMED ON MULTIPLE VIEWS. SUBSEQUENT ANGIOGRAPHIC RUNS SHOWED SIGNIFICANT CONTRAST STASIS OF THE ANEURYSMS WITHOUT PARENT VESSEL OCCLUSION. THE MICROCATHETERS WERE REMOVED. FINAL ANGIOGRAPHIC RUNS OF THE RIGHT INTERNAL CAROTID ARTERY AGAIN DEMONSTRATED SIGNIFICANT CONTRAST STASIS OF THE RIGHT M1 AND M2 ANEURYSMS. THE CATHETER WAS REMOVED. AN ANGIOSEAL CLOSURE DEVICE WAS USED FOR GROIN CLOSURE WITHOUT ANY COMPLICATIONS. THE PROCEDURE WAS COMPLETED. THE OUTCOME WAS RESOLVED. ADDITIONAL INFORMATION CONFIRMED THAT A COMPETITOR¿

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 25250300 ↗
• MalfunctionApr 21, 2025Premature Separation; Premature Separation

  AS REPORTED, THE COIL DEPLOYED IN THE MICROCATHETER IN THE PATIENT BY ITSELF WITHOUT ACTUALLY BEING DETACHED. COIL WAS REMOVED ALONG WITH THE HEADWAY 17 MICROCATHETER. WAS NOT LEFT IN THE PATIENT. THE DEVICE IS AVAILABLE FOR RETURN AND INVESTIGATION. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876445 ↗
• InjuryMay 14, 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 #: 1 EVENT START DATE: 06/MAR/2023 POST OPERATIVE DAYS: 292 DAYS EVENT DESCRIPTION : RECANALIZATION REQUIRING RETREATMENT. ASYMPTOMATIC. AE OUTCOME : RESOLVED WITHOUT SEQUELAE EVENT WAS REVIEWED BY INDEPENDENT REVIEWER (CEA) AND WAS DETERMINED TO BE DEFINITELY RELATED TO STUDY DEVICE AND PROBABLY RELATED TO STUDY PROCEDURE. THE INITIAL TREATMENT DATE: (B)(6) 2023 INITIAL TREATMENT: MIDLINE ANTERIOR COMMUNICATING ARTERY RETREATMENT PERFORMED, INTRASACULAR DEVICE WAS PLACED ON (B)(6) 2024.

  Patient problems: Aneurysm

  MAUDE report 19316004 ↗
• InjuryMay 13, 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 #: 2. RECANALIZATION OF PREVIOUSLY TREATED RIGHT ANTERIOR COMMUNICATING ARTERY RUPTURED ANEURYSM ON (B)(6) 2021. RETREATMENT COMPLETED AND IMPROVED RECANALIZATION. AE OUTCOME : RESOLVED WITHOUT SEQUELAE. INDEPENDENT REVIEWER (CEA) DETERMINED TO BE DEFINITELY RELATED TO STUDY DEVICE AND PROBABLY RELATED TO STUDY PROCEDURE. EVENT START DATE: 23/SEP/2021. POST OPERATIVE DAYS: 85 DAYS. AE OUTCOME: RESOLVED WITHOUT SEQUELAE.

  Patient problems: Aneurysm

  MAUDE report 19306560 ↗
• InjuryMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ENROLLED IN THE RAGE CLINICAL STUDY WAS PREVIOUSLY TREATED WITH EMBOLIZATION COIL IMPLANTS ON (B)(6) 2019 FOR RUPTURED PCOM ANEURYSM. THE ANEURYSM LATER REBLED ON (B)(6(2020. A STENT WAS IMPLANTED TO TREAT THE RUPTURED ANEURYSM. IT WAS REPORTED TO HAVE RESOLVED WITHOUT SEQUELAE. THE EVENT WAS ATTRIBUTED TO THE "STUDY DISEASE (ENDOVASCULAR PROCEDURE)"

  Patient problems: Ruptured Aneurysm

  MAUDE report 16569639 ↗
• DeathJun 25, 2021Stretched; Stretched

  IT WAS REPORTED THAT EMBOLIZATION COILS WERE USED TO TREAT A SUBARACHNOID HEMORRHAGE (SAH) CAUSED BY RUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY (ACOM). SEVERAL COILS OF DIFFERENT SIZES WERE ATTEMPTED BY THE PHYSICIAN, WITHOUT SUCCESS. AFTER MULTIPLE MANIPULATIONS, ONE OF THE COILS STRETCHED DURING PARTIAL DEPLOYMENT TO A POINT WHERE THE PHYSICIAN WAS NOT ABLE TO REMOVE IT. STENTS WERE PLACED AND THE ACOM ARTERY WAS REPORTEDLY OCCLUDED, BUT THE PATIENT ULTIMATELY EXPIRED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12072039 ↗
• InjuryJun 18, 2021Stretched; Stretched

  IT WAS REPORTED THAT A PATIENT ENROLLED IN THE RAGE STUDY UNDERWENT TREATMENT FOR A ANEURYSM OF THE RIGHT PCOM. DURING THE EMBOLIZATION, A COIL IMPLANT BEGAN TO STRETCH AND WAS REMOVED IN ITS ENTIRETY WITH THE MICROCATHETER. FOLLOWING THIS, THERE WAS CLOT SEEN IN THE M3 SEGMENT OF THE RIGHT MCA BRANCH. THE CLOT WAS CLEARED WITH WIRE MACERATION. ADDITIONAL HEPARIN WAS GIVEN DURING THE PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT WAS NEUROLOGICALLY INTACT. THE OUTCOME WAS REPORTED AS "RESOLVED WITHOUT SEQUELAE" ON (B)(6) 2021.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12028243 ↗
• MalfunctionFeb 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE RETRACTING THE EMBOLIZATION COIL TO REPOSITION IT IN THE VESSEL, THE COIL PREMATURELY DETACHED IN THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8337538 ↗