StentRecalls & reported problems across all models
Microvention, Inc. · 63 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Stent model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 237
- Deaths reported
- 11
- Injuries reported
- 191
- Recalls
- 2
We found 63 models of Stent by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 237 adverse event reports in the FDA's MAUDE database, received between Mar 27, 2020 and Sep 24, 2026 — classified as 11 deaths, 191 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (29 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
Stent recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 5, 2025Open, Classified
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
Z-0108-2026 · Root cause: Device Design · names 9 of these models · Recall details · FDA record ↗
- Jun 7, 2023Open, Classified
Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
Z-2238-2023 · Root cause: Process control · names 19 of these models · Recall details · FDA record ↗
Most reported Stent problems
Device problems
- Adverse Event Without Identified Device or Use Problem124
- Activation Failure29
- Activation Problem22
- Retraction Problem21
- Migration19
- Unintended Movement9
- Material Twisted/Bent6
- Difficult to Open or Close4
Patient problems
- Thrombosis/Thrombus86
- No Clinical Signs, Symptoms or Conditions69
- Stroke/CVA21
- Obstruction/Occlusion20
- Muscle Weakness/Atrophy19
- Thrombus14
- Ischemia Stroke13
- Stenosis9
Stent models
63 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Stent FREDX5522-PMAIntracranial aneurysm flow diverter1 recall9 reports
- Stent FRED4007-PMAIntracranial aneurysm flow diverter1 recall1 death8 reports
- Stent FRED4012-PMAIntracranial aneurysm flow diverter1 recall1 death8 reports
- Stent FRED4017-PMAIntracranial aneurysm flow diverter1 recall8 reports
- Stent FREDX5015-PMAIntracranial aneurysm flow diverter1 recall8 reports
- Stent FRED3516-PMAIntracranial aneurysm flow diverter1 recall5 reports
- Stent FRED4508-PMAIntracranial aneurysm flow diverter1 recall5 reports
- Stent FRED5514-PMAIntracranial aneurysm flow diverter1 recall5 reports
- Stent FREDX3513-PMAIntracranial aneurysm flow diverter1 recall5 reports
- Stent FREDX4515-PMAIntracranial aneurysm flow diverter1 recall5 reports
- Stent FREDX4525-PMAIntracranial aneurysm flow diverter1 recall5 reports
- Stent FRED4518-PMAIntracranial aneurysm flow diverter1 recall4 reports
- Stent FRED3507-PMAIntracranial aneurysm flow diverter1 recall1 death3 reports
- Stent FRED5019-PMAIntracranial aneurysm flow diverter1 recall3 reports
- Stent FREDX4013-PMAIntracranial aneurysm flow diverter1 recall1 death3 reports
- Stent FRED3511-PMAIntracranial aneurysm flow diverter1 recall2 reports
- Stent FRED4026-PMAIntracranial aneurysm flow diverter1 recall1 death2 reports
- Stent FRED4513-PMAIntracranial aneurysm flow diverter1 recall2 reports
- Stent FRED5014-PMAIntracranial aneurysm flow diverter1 recall2 reports
- Stent FREDX3517-PMAIntracranial aneurysm flow diverter1 recall2 reports
- Stent FREDX3522-PMAIntracranial aneurysm flow diverter1 recall2 reports
- Stent FREDX5532-PMAIntracranial aneurysm flow diverter1 recall2 reports
- Stent FRED3524-PMAIntracranial aneurysm flow diverter1 recall1 report
- Stent FRED5009-PMAIntracranial aneurysm flow diverter1 recall1 report
- Stent FRED5029-PMAIntracranial aneurysm flow diverter1 recall1 report
- Stent FRED5526-PMAIntracranial aneurysm flow diverter1 recall1 report
- Stent FRED4038-PMAIntracranial aneurysm flow diverter1 recall0 reports
- Stent FRED4539-PMAIntracranial aneurysm flow diverter1 recall0 reports
- Stent FREDX4520-PMAIntracranial aneurysm flow diverter1 death12 reports
- Stent FREDX2518-PMAIntracranial aneurysm flow diverter11 reports
- Stent FREDX4023-PMAIntracranial aneurysm flow diverter1 death10 reports
- Stent FREDX4018-PMAIntracranial aneurysm flow diverter9 reports
- Stent FRED2513-PMAIntracranial aneurysm flow diverter2 deaths8 reports
- Stent LEV3018-PMAIntracranial coil-assist stent7 reports
- Stent FREDX3013-PMAIntracranial aneurysm flow diverter6 reports
- Stent FREDX3019-PMAIntracranial aneurysm flow diverter6 reports
- Stent FRED2508-PMAIntracranial aneurysm flow diverter5 reports
- Stent FRED3009-PMAIntracranial aneurysm flow diverter5 reports
- Stent FRED4528-PMAIntracranial aneurysm flow diverter5 reports
- Stent LEV2517-PMAIntracranial coil-assist stent5 reports
- Stent FRED3021-PMAIntracranial aneurysm flow diverter4 reports
- Stent FREDX5021-PMAIntracranial aneurysm flow diverter4 reports
- Stent FREDX5026-PMAIntracranial aneurysm flow diverter1 death4 reports
- Stent LEV2522-PMAIntracranial coil-assist stent4 reports
- Stent LEV3024-PMAIntracranial coil-assist stent4 reports
- Stent FRED3014-PMAIntracranial aneurysm flow diverter3 reports
- Stent FREDX2513-PMAIntracranial aneurysm flow diverter3 reports
- Stent FRED2520-PMAIntracranial aneurysm flow diverter2 reports
- Stent FREDX2525-PMAIntracranial aneurysm flow diverter2 reports
- Stent FREDX5036-PMAIntracranial aneurysm flow diverter1 death2 reports
- Stent LEV3522-PMAIntracranial coil-assist stent2 reports
- Stent FRED3536-PMAIntracranial aneurysm flow diverter1 report
- Stent FREDX3027-PMAIntracranial aneurysm flow diverter1 report
- Stent FREDX3531-PMAIntracranial aneurysm flow diverter1 report
- Stent FREDX4032-PMAIntracranial aneurysm flow diverter1 report
- Stent FREDX4044-PMAIntracranial aneurysm flow diverter1 report
- Stent FREDX4534-PMAIntracranial aneurysm flow diverter1 report
- Stent FREDX4545-PMAIntracranial aneurysm flow diverter1 report
- Stent LEV2512-PMAIntracranial coil-assist stent1 report
- Stent LEV3517-PMAIntracranial coil-assist stent1 report
- Stent LEV3528-PMAIntracranial coil-assist stent1 report
- Stent LEV4021-PMAIntracranial coil-assist stent1 report
- Stent LEV4027-PMAIntracranial coil-assist stent1 report
Recent Stent adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Muscle Weakness/Atrophy
MAUDE report 50876580 ↗InjurySep 5, 2026Activation Failure
Patient problems: Stenosis
MAUDE report 50624980 ↗MalfunctionJun 8, 2026Retraction Problem
IT WAS REPORTED THAT THE COIL-ASSIST STENT WAS BEING USED IN AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM EMBOLIZATION PROCEDURE. THE STENT INTRODUCED INTO THE CATHETER WITHOUT INCIDENT; HOWEVER, WHEN THE PHYSICIAN TRIED TO DEPLOY IT, THE STENT WOULD NOT OPEN DISTALLY. THE PHYSICIAN THEN TRIED TO RECAPTURE THE STENT AND WAS NOT ABLE TO. THE PHYSICIAN REMOVED THE ENTIRE STENT/CATHETER SYSTEM AND USE A DIFFERENT DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PATIENT, WHO WAS REPORTED IN A STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25437285 ↗InjuryJun 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH A CAR REGISTRY STUDY THAT THE SUBJECT EXPERIENCED A BLISTER ANEURYSM. AN ATTEMPT WAS MADE TO TREAT THE ANEURYSM BY COILING, AND THEN AFTER THE COILS KEPT FALLING OUT DUE TO THE ANEURYSM TYPE. THE PHYSICIAN THEN PLACED AN LVIS STENT TO CONDUCT STENT ASSISTED COILING TO TREAT THE ANEURYSM. AT 31 DAYS POST PROCEDURE, FLUOROSCOPIC IMAGING REVEALED THE DEVELOPMENT OF IN STENT STENOSIS. THIS COMPLICATION WAS TREATED WITH A THROMBECTOMY. THE OUTCOME WAS RESOLVED. IT WAS NOTED: EVENT NUMBER: 1 ADVERSE EVENT TERM: IN STENT PARTIAL OCCLUSION RELATIONSHIP TO STUDY DEVICE: RELATED RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: DEFINITELY RELATED RELATIONSHIP TO USE OF ANCILLARY DEVICE: NOT RELATED RELATIONSHIP TO STUDY DISEASE: NOT RELATED RELATIONSHIP TO CONCURRENT DISEASE: NOT RELATED RELATIONSHIP TO DUAL ANTIPLATELET THERAPY: NOT RELATED. PLEASE NOTE THAT THE COILS USED TO TREAT THE BLISTERING ANEURYSM ARE CONSIDERED NOT RELATED TO THE STUDY DEVICE. THEY ARE CONSIDERED ANCILLARY DEVICES USED IN THIS CASE. THE STENT USED IN THIS CASE IS CONSIDERED TO BE RELATED TO THE STUDY DEVICE, LVIS EVO.
Patient problems: Thrombosis/Thrombus
MAUDE report 25422363 ↗InjuryApr 22, 2026Structural Problem; Material Twisted/Bent
AS REPORTED THROUGH THE (B)(6) CLINICAL STUDY: THE LAB REPORTED DISTAL FISHMOUTHING 25-50%, EXACT PERCENTAGE IS NOT KNOWN. FISHMOUTHING WAS OBSERVED BY THE LAB ON THE 6 MONTH FOLLOW-UP IMAGING, POST DETACHMENT. THE LAB ALSO REPORTED (B)(6) BRAID BUMP DEFORMATION AT THE 6 MONTH FOLLOW-UP IMAGING. THE 6 MONTH FOLLOW-UP IMAGING WAS PERFORMED A YEAR PRIOR TO THE LAB REVIEWING THE IMAGING. FISH-MOUTHING WAS ALSO NOTED BY THE LAB ON THE 12 MONTH FOLLOW-UP IMAGING. THERE IS NO PLANNED INTERVENTION TO ADDRESS THE FISH-MOUTHING. THE TREATMENT SITE DURING THE INDEX PROCEDURE IS A LEFT SUPRACLINOID ANEURYSM. ANEURYSM IS FULLY OCCLUDED (RAYMOND-ROY 1). NO CORRESPONDING ADVERSE EVENT OR TREATMENT HAVE BEEN REPORTED FOR THIS SUBJECT. SUBJECT IS WAITING FOR 2 YEAR FOLLOW-UP VISIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958713 ↗InjuryApr 13, 2026Activation Problem
NO NEW INFORMATION PROVIDED. SEE SECTION B3 FOR DATE OF EVENT CORRECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865615 ↗MalfunctionApr 11, 2026Unintended Movement
IT WAS REPORTED THAT AT THE SIX-MONTH FOLLOW-UP IMAGING PERFORMED ON (B)(6) 2025, A FIVE MILLIMETER OR GREATER FRED X DEVICE MIGRATION WAS OBSERVED, WITH THE COMMENT THAT BOTH PROXIMAL AND DISTAL MARKERS HAD MOVED DISTALLY. IT WAS FURTHER REPORTED THAT, IN ADDITION TO THE MIGRATION, DISTAL BRAID COLLAPSE AND A BRAID BUMP WERE ALSO IDENTIFIED ON THE SAME SIX-MONTH FOLLOW-UP IMAGING. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS REPORTED AS "NO ADVERSE EVENTS WERE REPORTED". AND THE MODIFIED RANKIN SCALE SCORE REMAINED 0 AT BOTH THE SIX-MONTH AND TWELVE-MONTH FOLLOW-UP VISITS PERFORMED ON (B)(6) 2025 AND (B)(60 2026, RESPECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24850698 ↗InjuryApr 2, 2026Activation Problem
IT WAS REPORTED THAT A STENT WAS DIFFICULT TO DETACH. EVENTUALLY IT DID DETACH BUT IT DID NOT FULLY OPEN. IT WAS REPORTED THAT THERE WAS GOOD FLOW POST DEPLOYMENT. IT WAS REPORTED THAT ABOUT A WEEK LATER THE PATIENT STARTED TO EXPERIENCE MULTIPLE STROKES. THE VESSEL WHERE THE STENT IS HAS THROMBOSIS IN THE STENT.
Patient problems: Stroke/CVA; Thrombosis/Thrombus
MAUDE report 24769043 ↗InjuryApr 2, 2026Activation Problem
IT WAS REPORTED THAT A STENT WAS DIFFICULT TO DETACH. EVENTUALLY IT DID DETACH BUT THE THE PROXIMAL END DID NOT FULLY OPEN. THE PATIENT REMAINED OVERNIGHT DUE TO THE STENT NOT COMPLETELY OPENING. NO THROMBUS WAS OBSERVED IN THE UNOPENED PORTION AND THE PATIENT WAS DISCHARGED. LATER THE PATIENT EXPERIENCED A TIA. ANGIO REVEALED THAT THE STENT IS COMPLETELY OCCLUDED DUE TO THROMBUS.
Patient problems: Thrombosis/Thrombus; Transient Ischemic Attack
MAUDE report 24767686 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH THE FRED X PAS CLINICAL STUDY: ANEURYSM OCCLUSION DECREASED FROM 90% AT 6 MONTH TO 85% AT 12 MONTH. EVENT TERM : WORSENING IN OCCLUSION DATE SITE WAS MADE AWARE OF THE EVENT : 11-APR-2025 RELATIONSHIP TO DEVICE: POSSIBLE RELATIONSHIP TO PROCEDURE: NOT RELATED NO TREATMENT PERFORMED FOT THE ANEURYSM. NO ADDITIONAL AES. PT IS ASYMPTOMATIC. RETREATMENT HAS NOT BEEN SCHEDULED OR PERFORMED YET.
Patient problems: Obstruction/Occlusion
MAUDE report 24737038 ↗InjuryMar 30, 2026Activation Problem
IT WAS REPORTED FOR A PATIENT ENROLLED IN THE CAR (COMPLEX ANEURYSM REGISTRY) STUDY THAT A SEGMENT OF A FREDX DEVICE DID NOT COMPLETELY OPEN DURING PROCEDURE. A NON-RUPTURED, RIGHT MCA BIFURCATION ANEURYSM WAS TREATED WITH A FREDX DEVICE. THE SPONSOR REVIEW OF INDEX PROCEDURE NOTE IDENTIFIED A SEGMENT OF A FREDX DEVICE DID NOT COMPLETELY OPEN DURING PROCEDURE. AT THIS TIME, THE FRED-X DELIVERY SYSTEM WAS TAKEN THROUGH THE MICROCATHETER. THE DEVICE WAS DEPLOYED WITH THE DISTAL LANDING ZONE NEAR THE OPHTHALMIC ARTERY AND THE PROXIMAL LANDING JUST PROXIMAL TO THE HORIZONTAL PETROUS SEGMENT. THERE WAS GOOD WALL APPOSITION OF THE DEVICE ON INTERMITTENT ANGIOGRAPHY PROXIMALLY AND DISTALLY OUT BUT THERE WAS A SEGMENT THAT DIDN'T APPEAR TO OPEN FULLY ACROSS THE PROXIMAL PORTION OF THE ANEURYSM NECK. FOR THIS REASON, WE DECIDED TO ANGIOPLASTY THE DEVICE. THE MICROCATHETER WAS TAKEN BACK OVER THE DELIVERY WIRE THROUGH THE PROXIMAL 2/3'S OF THE STENT FOLLOWED BY COMPLETE WITHDRAWAL OF THE DELIVERY WIRE. THE GUIDEWIRE WAS THEN INSERTED THROUGH THE MICROCATHETER AND ADVANCED OUT OF THE FLOW DIVERTING STENT AND INTO THE RIGHT M1. THE MICROCATHETER WAS EXCHANGED OFF FOR THE BALLOON. THE BALLOON W
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715745 ↗InjuryMar 25, 2026Material Fragmentation
AS REPORTED: STENT WAS PLACED WITH DIFFICULTY, HOWEVER, POST IMPLANTATION ANGIOS SHOWED A SUCCESSFUL PROCEDURE. LATER, SMALL STRANDS WERE NOTED ON CT. PHYSICIAN ASSUMES THAT THESE STRANDS WERE FROM A PART OF THE STENT THAT HAD BROKEN OFF. PATIENT HAD A STROKE BUT HAS SUBSEQUENTLY RECOVERED ASIDE FROM SOME LINGERING ARM NUMBNESS. NO INTERVENTION WAS PERFORMED ON THE STROKE NOR IS ONE PLANNED. THE PATIENT HAS MOSTLY IMPROVED NOW. PHYSICIAN ATTRIBUTES THE STROKE TO THE OVERALL DIFFICULTY OF THE CASE, NOT TO THE LVIS EVO. PHYSICIAN HAD TO DO SIGNIFICANT MANIPULATION OF THE CATHETER AND WIRE TO GET ACCESS AND THE PLACEMENT WAS TOUGH, SO HE THINKS THAT CAUSED THE STROKE.
Patient problems: Numbness
MAUDE report 24694029 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE FRED X POST-APPROVAL STUDY (PAS) THAT DURING A SIX-MONTH DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) EVALUATION, THE PATIENTS RIGHT OPHTHALMIC ARTERY WAS OBSERVED TO BE COMPLETELY OCCLUDED. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED NO ASSOCIATED SYMPTOMS. THE ADVERSE EVENT WAS REPORTED TO BE ONGOING AT THE TIME OF DOCUMENTATION, WITH NO RESOLUTION DATE PROVIDED.
Patient problems: Obstruction/Occlusion
MAUDE report 24671666 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED: A CLOT FORMED ON THE PROXIMAL END OF THE FREDX. INTEGRILIN WAS GIVEN. THE ANEURYSM RUPTURED AND AN EVD WAS PLACED. I AM NOT AWARE OF OUTCOME.
Patient problems: Ruptured Aneurysm; Thrombosis/Thrombus
MAUDE report 24614237 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE FLOW DIVERTER STENT WAS USED TO TREAT A PATIENT WITH MALFORMATION IN PROXIMAL ICA MEASURING 3.0MM DISTAL, AND 3.52MM PROXIMAL. THE PATIENT STAYED IN THE HOSPITAL FOR FOUR DAYS DUE TO HEADACHE, WHEN DISCHARGED ON (B)(6) 2026. REPORTEDLY, FIVE DAYS POST DISCHARGE - THE PATIENT CAME BACK WITH HEADACHE AND LEFT SIDE WEAKNESS. DIGITAL SUBTRACTION ANGIOGRAPHY WAS PERFORMED AND THROMBECTOMY WAS ATTEMPTED ON (B)(6), 2026 BUT FAILED AS IT "COULD NOT GET THROUGH WITH WIRE." BREILENTA P2612 - 14 AND P2Y12 - 55 TRIPLE THERAPY WAS ADMINISTERED AND THE CASE COMPLETED SUCCESSFULLY. PATIENT OUTCOME REPORTED AS "TRIPLE THERAPY WITH NO COMPLICATIONS."
Patient problems: Headache; Muscle Weakness/Atrophy
MAUDE report 24610312 ↗
Other Microvention, Inc. products
- Azur CX Detachable22 models · 509 reports · 1 recall
- Azur Detachable Helical HydroCoil42 models · 190 reports
- V-Trak75 models · 147 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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