V-TrakRecalls & reported problems across all models
Microvention, Inc. · 75 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 147
- Deaths reported
- 6
- Injuries reported
- 76
- Recalls
- 0
We found 75 models of V-Trak by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 147 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2017 and Jul 1, 2026 — classified as 6 deaths, 76 injuries, 65 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (53 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported V-Trak problems
Device problems
- Detachment of Device or Device Component53
- Adverse Event Without Identified Device or Use Problem30
- Premature Separation18
- Stretched18
- Detachment Of Device Component14
- Separation Failure12
- Unraveled Material8
- Component Missing6
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- No Consequences Or Impact To Patient28
- Aneurysm13
- Thrombosis/Thrombus8
- Ruptured Aneurysm6
- No Known Impact Or Consequence To Patient4
- Stroke/CVA4
- Death3
V-Trak models
75 models, most reported first. Each model has its own page with its reports, recalls and device details.
- V-Trak 7110-0515-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 death8 reports
- V-Trak 7110-0306-3D-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 death8 reports
- V-Trak 100206HS-V-A2DEVICE, NEUROVASCULAR EMBOLIZATION7 reports
- V-Trak 7110-0408-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 death6 reports
- V-Trak 7110-0510-A2Device, Vascular, for Promoting Embolization6 reports
- V-Trak 100306HS-V-A2Device, Vascular, for Promoting Embolization5 reports
- V-Trak 100204HS-V-A2Device, Vascular, for Promoting Embolization4 reports
- V-Trak VFC061020-V-A2DEVICE, NEUROVASCULAR EMBOLIZATION4 reports
- V-Trak 7110-0405-A2Device, Vascular, for Promoting Embolization4 reports
- V-Trak 7110-0619-A2Device, Vascular, for Promoting Embolization4 reports
- V-Trak 100308HS-V-A2Device, Vascular, for Promoting Embolization3 reports
- V-Trak 8410-0203-A2DEVICE, NEUROVASCULAR EMBOLIZATION2 deaths3 reports
- V-Trak 7110-0612-A2Device, Vascular, for Promoting Embolization3 reports
- V-Trak 7110-0728-A2DEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- V-Trak 7110-1036-A2Device, Vascular, for Promoting Embolization3 reports
- V-Trak 7110-0254-3D-A2Device, Vascular, for Promoting Embolization3 reports
- V-Trak 8410-0304-A2Device, Vascular, for Promoting Embolization2 reports
- V-Trak 8410-0515-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 death2 reports
- V-Trak 7210-0154-A2Device, Vascular, for Promoting Embolization2 reports
- V-Trak 7210-0254-A2Device, Vascular, for Promoting Embolization2 reports
- V-Trak 7310-0515-A2Device, Vascular, for Promoting Embolization2 reports
- V-Trak 7310-1030-A2Device, Vascular, for Promoting Embolization2 reports
- V-Trak 7110-0715-A2DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- V-Trak 7110-0817-A2DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- V-Trak 7110-0931-A2DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- V-Trak 7118-0827-A2DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- V-Trak 7118-2048-A2DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- V-Trak 7110-0415-A2Device, Vascular, for Promoting Embolization2 reports
- V-Trak 7110-0520-A2DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- V-Trak 7110-0202-3D-A2DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- V-Trak 100208HCSR-S-V-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 100310HCSR-S-V-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 100830HCSR-R-V-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 8510-0202-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 8510-0204-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 8510-0256-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 8510-0308-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 8510-0508-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 8410-0204-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 8410-0254-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 8410-0306-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 8410-0408-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 100307CC-V-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 100718CC-V-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 8210-0522-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 8210-0837-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 8210-0933-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 180620HC-R-V-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 180730HC-R-V-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 180930HC-R-V-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 180204HC-S-V-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 180308HC-S-V-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 180410HC-S-V-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 180512HC-S-V-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 8310-1030-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 7210-0152-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 7210-0203-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 7210-0208-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 7210-0308-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 7210-0515-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 7310-0615-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 7310-0720-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 7310-0820-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 7310-1230-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 7110-0833-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 7118-0931-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 7118-1139-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 7118-1243-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 7118-1644-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 100306HCSR-S-V-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 8218-1139-A2Device, Vascular, for Promoting Embolization1 report
- V-Trak 8410-0208-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 8410-0258-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 8410-0308-A2DEVICE, NEUROVASCULAR EMBOLIZATION1 report
- V-Trak 8410-0310-A2Device, Vascular, for Promoting Embolization1 report
Recent V-Trak adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJun 30, 2026Unraveled Material
AS REPORTED: THE COIL STRETCHED AND UNWOUND AND NEEDED TO BE TACKED DOWN WITH A STENT. DURING RECAPTURE AND TRYING TO REPOSITION MULTIPLE TIMES THE COIL BECAME COMPROMISED OR DAMAGED AND WHEN PULLED BACK INTO MICROCATHETER STRETCHED. ATTEMPTS WERE MADE TO REMOVE BUT WOULD HAVE CAUSED DISRUPTION OF COIL MASS SO DECISION WAS MADE TO LEAVE. FOLLOW UP SHOWED NO IMMEDIATE ISSUE OR COMPLICATION. PHYSICIAN WILL DUE FOLLOW UP IN 6 MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673262 ↗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 ↗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 ↗InjuryMay 19, 2026Unraveled Material; Premature Separation
AS REPORTED: EMBOLIZATION COIL UNRAVELED AND BROKE APART, IS RETAINED INSIDE THE LEFT ICA OF PATIENT.
Patient problems: Insufficient Information
MAUDE report 25219921 ↗InjuryMar 31, 2026Unraveled Material; Difficult to Advance
IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS USED TO TREAT A PATIENT WITH AN ACOMM ANEURYSM. REPORTEDLY, IT WAS DIFFICULT TO ADVANCE THE COIL AND THE PHYSICIAN ATTEMPTED TO PULL THE COIL BACK INTO THE SHEATH WHEN THE COIL STARTED TO UNRAVEL AND WOULD NOT GO BACK INTO THE SHEATH. THE COIL WAS REMOVED FROM THE PATIENT AND THE CASE WAS ABORTED AS THE COIL COULD NOT BE PLACED IN THE ANEURYSM. NO COILS WERE IMPLANTED DURING THE CASE. REPORTEDLY, VESSEL ANATOMY WAS THE MAIN REASON WHY PHYSICIAN WAS UNABLE TO TREAT THE ANEURYSM. AT THE END OF PROCEDURE, THE PATIENT WAS THE SAME AS PRE PROCEDURE AND CURRENTLY "BASELINE." THE PHYSICIAN PLANS TO BRING THE PATIENT TO SURGERY TO CLIP THE ANEURYSM; HOWEVER, NO DATE IS SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24743085 ↗MalfunctionMar 31, 2026Premature Separation
IT WAS REPORTED THAT DURING AN ANEURYSM TREATMENT PROCEDURE, ONE OF THE COILS FAILED TO DETACH USING TWO DETACHMENT CONTROLLERS. THE USER DECIDED TO REMOVE THE CATHETER TO REMOVE THE COIL. REPORTEDLY, DURING REMOVAL, THE COIL UNINTENTIONALLY DETACHED FROM THE CATHETER. THE CATHETER AND COIL WERE REMOVED FROM THE PATIENT. THE USER THEN PERFORMED A TEST USING BOTH DETACHMENT CONTROLLERS, BUT NEITHER WORKED ON THIS COIL. THE CONTROLLERS WORKED ON A COIL FROM ANOTHER BATCH, ALLOWING THE PROCEDURE TO CONTINUE. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24743018 ↗InjuryMar 19, 2026Stretched; Premature Separation
IT WAS REPORTED THAT THE PHYSICIAN WAS TREATING AN ARTERIOVENOUS MALFORMATION (AVM) USING BOTH MICROVENTION COILS AND COMPETITOR COILS. THE PHYSICIAN DEPLOYED ONE OF THE COMPETITOR COILS FIRST AND THEN PROCEEDED WITH THE MICROVENTION DEVICE. AFTER DEPLOYMENT THE PHYSICIAN WAS ATTEMPTING TO GET THE DEVICE TO FORM IN THE INTENDED LOCATION, AND DURING POSITIONING HALF OF THE COIL WAS IN THE VEIN AND THE OTHER HALF PREMATURELY DETACHED IN THE MICROCATHETER IN THE AORTA. AFTER UNSUCCESSFUL ATTEMPTS TO SNARE THE COIL, HE PROCEEDED WITH THE EMBOLIZATION. THE COIL WAS LEFT IN THE PATIENT AND COMPLETED THE EMBOLIZATION WITH THE PROXIMAL END OF THE COIL IN THE AORTA. NO ADDITIONAL PATIENT INFORMATION WAS MADE AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24640511 ↗MalfunctionMar 7, 2026Difficult or Delayed Positioning
IT WAS REPORTED THAT DURING A PROCEDURE THE COIL DID NOT RELEASE. A SECOND CONTROLLER OF A DIFFERENT LOT WAS USED; HOWEVER, THE SAME FAILURE WAS EXPERIENCED. IT WAS REPORTED THAT STANDARD TECHNICAL RECOMMENDATIONS WERE FOLLOWED, INCLUDING MOISTENING THE GOLD TIP OF THE COIL AND ROTATING THE CONTROLLER TO FACILITATE RELEASE. DESPITE THESE EFFORTS, THE AUDIBLE RELEASE SIGNAL WAS NOT HEARD ON ANY ATTEMPT, AND THE INDICATOR LIGHT CHANGED FROM GREEN TO ORANGE WITHOUT CONFIRMING DEPLOYMENT. IT WAS REPORTED THAT UNDER FLUOROSCOPIC GUIDANCE, THE COIL WAS CONFIRMED NOT TO HAVE RELEASED. THE PHYSICIAN PROCEEDED TO REMOVE THE SYSTEM, AND THROUGH COUNTER-TRACTION, THE COIL DETACHED WHILE REMAINING WITHIN THE MICROCATHETER. THE COIL WAS THEN POSITIONED WITHIN THE ANEURYSM USING ADVANCEMENT MANEUVERS WITH THE PUSHER, WHERE IT WAS ULTIMATELY IMPLANTED. THERE WAS NO PATIENT INJURY. IT IS INDICATED THAT THE PATIENT WAS IN GOOD CLINICAL CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24540365 ↗InjuryFeb 6, 2026Separation Problem; Premature Separation
AS REPORTED THROUGH THE CLINICAL STUDY CAR: DEVICE DEFICIENCY DESCRIPTION: DURING PLACEMENT AND REPOSITIONING OF THE FINAL COIL, THE PROXIMAL ASPECT OF THE COIL BEGAN TO STRETCH. IN TRYING TO RECOVER THE COIL, THE COIL FRACTURED COMPLETELY AND SEPARATED. ADDITIONAL INFORMATION RECEIVED CLARIFIED ¿COIL FRACTURED¿ TO MEAN THE PRODUCT DETACHED WHILE IN THE PATIENT AND WAS LEFT IN THE SUBJECT. A SECOND COIL WAS DEPLOYED TO PREVENT MIGRATION/THROMBUS. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS NOTED: DID SUBJECT REQUIRE OTHER TREATMENT/INTERVENTION AS A RESULT OF THE MALFUNCTION/DEFICIENCY THAT IS NOT ASSOCIATED WITH ANY ADVERSE EVENT? Y (YES) COULD THIS DEVICE DEFICIENCY HAVE LED TO A SERIOUS ADVERSE DEVICE EFFECT (SADE): 1. IF EITHER SUITABLE ACTION HAD NOT BEEN TAKEN, 2. IF INTERVENTION HAD NOT BEEN MADE, OR 3. IF CIRCUMSTANCES HAD BEEN LESS FORTUNATE: Y (YES) NO OTHER CLARIFICATION OR INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24284883 ↗InjuryDec 19, 2025Device Dislodged or Dislocated; Premature Separation; Device Dislodged or Dislocated; Premature Separation
IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WAS DEPLOYED AND DETACHED IN A COIL MASS OF MULTIPLE COILS. WHILE THEY WERE PLACING THE LAST COIL, IT DETACHED UNEXPECTEDLY WITH HALF OF THE COIL LENGTH IN THE ANEURYSM AND THE OTHER HALF LEFT IN THE PARENT VESSEL. IT WAS REPORTED THAT THE PATIENT IS FINE AND THE SURGEON IS NOT CONCERNED. THE SURGEON PLACED STENTS ALONG SIDE THE PORTION OF THE COIL THAT WAS STILL IN THE VESSEL TO "PIN IT" SO IT WOULD NOT MIGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23847124 ↗MalfunctionNov 22, 2025Premature Separation; Premature Separation
NO ADDITIONAL INCIDENT INFORMATION WAS RECEIVED; HOWEVER THE EVALUATION OF THE RETURNED DEVICE IS COMPLETED. PLEASE SEE H6 & H11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23625120 ↗MalfunctionNov 6, 2025Premature Separation; Premature Separation
AS REPORTED: DURING A COILING PROCEDURE FOR TREATMENT OF LMCA ANEURYSM, THE 2ND COIL PREMATURELY DETACHED IN HEADWAY DUO MICROCATHETER WHILE HE WAS PUSHING IT IN. THE PHYSICIAN REMOVED BOTH THE MICROCATHETER AND THE COIL THAT WAS INSIDE. OPENED ANOTHER COIL AND HEADWAY DUO AND PROCEEDED TO FINISH THE EMBOLIZATION. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION PERFORMED. THERE WAS NO PATIENT IMPACT OR INJURY, THE PATIENT IS STABLE. DEVICES IN QUESTION WERE DISCARDED. NO OTHER INCIDENT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490610 ↗MalfunctionSep 2, 2025Premature Separation; Premature Separation
AS REPORTED: DURING MCA ANEURYSM COILING, THE PHYSICIAN WAS USING THIS HYDROFILL COIL WHEN IT BECAME LOOSE FROM THE PUSHER WIRE IN THE DISTAL PORTION OF THE HEADWAY DUO BEFORE REACHING THE TARGETED ANEURYSM. THE DUO WAS PULLED OUT WITH THE COIL INSIDE AND THEY WERE ABLE TO PUSH THE COIL OUT OF THE DUO. ANOTHER COIL WAS USED AND THE CASE CONTINUED AS PLANNED WITH NO INJURY TO THE PATIENT. NO OTHER INCIDENT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929690 ↗InjuryJul 11, 2025Separation Failure; Separation Problem; Separation Failure; Separation Problem
AS REPORTED, THE DETACHER WOULD GIVE A GREEN LIGHT UPON TESTING INDICATING A GOOD CONNECTION BUT THEN WHEN THE BUTTON WAS DEPRESSED, ONLY A SINGLE BEEP WAS HEARD. THIS HAPPENED MULTIPLE TIMES EVEN AFTER WIPING THE PUSHER DOWN WITH GAUZE. DURING MANIPULATION OF THE COIL, IT RUPTURED THROUGH THE ANEURYSM. THE PHYSICIAN WAS ABLE TO GET THE COIL DETACHED AND QUICKLY INTRODUCE ANOTHER COIL TO STOP THE BLEEDING. THE PATIENT WAS UNHARMED. ADDITIONAL INFORMATION INDICATED THAT THE DETACHMENT DIFFICULTY REQUIRING MANIPULATION OF THE FIRST COIL RUPTURED THE ANEURYSM.
Patient problems: Ruptured Aneurysm
MAUDE report 22487765 ↗
Other Microvention, Inc. products
- Azur CX Detachable22 models · 509 reports · 1 recall
- Stent63 models · 237 reports · 2 recalls
- Azur Detachable Helical HydroCoil42 models · 190 reports
- WEB14 models · 134 reports
- AZUR14 models · 104 reports
- HydroSoft 3D26 models · 101 reports
- MicroPlex Helical Soft9 models · 8 reports · 1 recall
- ERIC Retrieval Device3 models · 5 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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