V-Trak 7110-0510-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816777023674), received between Apr 2, 2021 and Jan 15, 2025 — classified as 4 injuries, 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2025Material Fragmentation; Unintended Movement; Material Fragmentation; Unintended Movement

  IT WAS REPORTED: THE PREVIOUS 3 COILS WENT IN FINE THROUGH THE HEADWAY DUO. THEY THEN ATTEMPTED TO PLACE A HYDROFRAME 5X10 COIL. THIS COIL ENDED UP PUSHING OUT THE HEADWAY DUO PAST THE FRED X THAT WAS FULLY DEPLOYED AND COULD NOT ADVANCE BACK OVER THE COIL. IN THE EFFORT TO REMOVE THE COIL COMPLETELY, IT STRETCHED AND BROKE. THE COIL WAS LEFT BEHIND IN THE PATIENT JAILED AGAINST THE FRED X PLACED IN THE ANEURYSM. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INCIDENT INFORMATION WERE MADE, HOWEVER, NO INFORMATION HAS BEEN RECEIVED AT TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21161590 ↗
• MalfunctionAug 27, 2024Premature Separation; Premature Separation

  IT WAS REPORTED: THE PHYSICIAN ATTEMPTED TREATING ANEURYSM WITH A 5X3 WEB HOWEVER THE POSITIONING WAS NOT IDEAL, SO THEY REMOVED THE WEB AND ATTEMPTED TO COIL THRU THE CATHETER THAT WAS ALREADY IN PLACE IN THE ANEURYSM. RESISTANCE WAS MET WHEN ADVANCING THE 5X10 HYDRO FRAME INTO THE CATHETER. THEY DECIDED TO TAKE THE COIL OUT AND RESHEATH. THE HYDRO FRAME 10 WAS STUCK IN THE CATHETER, THE PUSHER WIRE CAME OUT, BUT COIL WAS DETACHED IN THE CATHETER. THE PROCEDURE WAS COMPLETED BY TAKING THE CATHETER OUT COMPLETELY WITH THE COIL INSIDE AND STARTING FRESH WITH A DUO 156, THREE COILS WERE IMPLANTED TO FINISH PROCEDURE. THE PATIENT IS STABLE; NO PATIENT IMPACT, INJURY OR INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077729 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED NOTES THE CONCOMITANT DEVICE HYDROSOFT 3D, LOT 1804235YC, SIZE 2 X 4 WAS CONFIRMED TO BE MODEL 7110-0204. NO OTHER INCIDENT INFORMATION WAS PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 20071587 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY RAGE: DURING THE EMBOLIZATION PROCEDURE, PATIENT DEVELOPED A SMALL NON-OCCLUSIVE THROMBUS. RESOLVED WITH INTRA-ARTERIAL INTEGRILIN INFUSION. EVENT TERM: THROMBUS. EVENT START DATE: 01/MAY/2020. POST OPERATIVE DAYS: 0 DAYS AE OUTCOME : RESOLVED WITHOUT SEQUELAE. EVENT WAS REVIEWED BY INDEPENDENT REVIEWER (CEA) AND WAS DETERMINED TO BE POSSIBLY RELATED TO STUDY DEVICE AND DEFINITELY RELATED TO STUDY PROCEDURE. THE RELATIONSHIP OF THE DEVICE TO THE REPORTED CONDITION COULD NOT DEFINITIVELY BE RULED OUT, AND THE REPORTED INCIDENT WAS DETERMINED TO BE POSSIBLY RELATED TO STUDY DEVICE AND DEFINITELY RELATED TO STUDY PROCEDURE, IN AS SUCH, THE EVENT IS BEING REPORTED. AS IT CANNOT BE DETERMINED WHICH COIL DEVICE MAY HAVE IMPACTED THE THROMBUS, HYDROFRAME 5X10, MODEL 7110-0510-A2, LOT 1910011WF WAS CHOSEN AS A DEFAULT. THE OTHER COIL USED IN THE PROCEDURE WILL BE LISTED AS A CONCOMITANT DEVICE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19388684 ↗
• MalfunctionDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RAGE STUDY, A PATIENT WITH A HISTORY OF HYPERTENSION AND HYPOTHYROIDISM PRESENTED WITH A ONE DAY HISTORY OF HEADACHES AND CONFUSION. THE PATIENT WAS FOUND TO HAVE DIFFUSE SUBARACHNOID HEMORRHAGE WITH AN ANTERIOR COMMUNICATING ARTERY ANEURYSM ON CTA. THE PATIENT UNDERWENT ENDOVASCULAR, BALLOON ASSISTED COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH EXCELLENT OBLITERATION OF ANEURYSM, CONSISTENT WITH RAYMOND ROY GRADE 1. THE PROCEDURE WAS COMPLICATED BY INTRAPROCEDURAL RUPTURE. REPORTEDLY, FOLLOWING INSERTION OF A HYDROFRAME 5MM X 10CM EMBOLIZATION COIL IMPLANT, THE COIL WAS NOTED TO BE PARTIALLY PROTRUDING THROUGH THE ANEURYSM WALL INTO THE SUBARACHNOID SPACE. A TRANSFORM BALLOON WAS INFLATED AND A SECOND COIL WAS RAPIDLY PLACED WITHOUT EVIDENCE OF EXTRAVASATION ON THE FOLLOWING INJECTION. THE LAST COIL IMPLANT (SEE MDR 2032493-2021-00503) PARTIALLY HERNIATED INTO THE ANTERIOR COMMUNICATING ARTERY, BUT WITHOUT EVIDENCE OF SURROUNDING THROMBOSIS OR FLOW LIMITATION. DYNA CT SHOWED EVIDENCE OF NEW HEMORRHAGE, HOWEVER, WITH MILD HYDROCEPHALUS NECESSITATING EVD INSERTION.

  Patient problems: Intracranial Hemorrhage; Ruptured Aneurysm

  MAUDE report 13015933 ↗
• InjuryApr 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A RUPTURED ANEURYSM OF ANTERIOR COMMUNICATING ARTERY WAS TREATED WITH AN EMBOLIZATION COIL IMPLANT. AT THE TIME OF POSITIONING THE COIL IMPLANT, THE PATIENT WAS NOTED TO HAVE A CHANGE IN MENTAL STATUS, WHICH WAS LIKELY A SEIZURE EVENT. AFTER SEDATION HAD BEEN GIVEN IN ADDITION TO SEIZURE MEDICATION AND PATIENT REFRAINED FROM ACTIVELY MOVING, THE PHYSICIAN WISHED TO REMOVE THE COIL AND USE A SMALLER ONE. THE IMPLANT DETACHED UPON ATTEMPTED RETRACTION INTO THE MICROCATHETER. THE PHYSICIAN LEFT THE COIL IN POSITION AND CHOSE TO END THE PROCEDURE AND TRANSFER THE PATIENT TO THE INTENSIVE CARE UNIT GIVEN THEIR "DECLINE AND NEUROLOGIC STATUS WITH RECENT SEIZURE ACTIVITY." FOLLOW-UP ANGIOGRAPHY WAS PERFORMED, ESTABLISHING THAT THERE WAS NO FILLING OF THE ANEURYSM. IT WAS NOTICED THAT THE LEFT ANTERIOR CEREBRAL ARTERY BRANCH WAS NOT FILLING AS IT HAD PREVIOUSLY, THE CAUSE OR SUSPECTED CAUSE OF WHICH WAS NOT STATED BY THE PHYSICIAN. AFTER THE PROCEDURE, THE PATIENT HAD A STROKE, THE CAUSE AND LOCATION OF WHICH WAS NOT STATED. IT WAS RELATED BY A HOSPITAL EMPLOYEE THAT IT MAY HAVE BEEN DUE A COIL TAIL PROTRUDING INTO THE PARENT ARTERY OR A PIECE OF GUIDEWIRE LEFT BEHIND,

  Patient problems: Stroke/CVA

  MAUDE report 11606723 ↗