Barricade Coil SystemRecalls & reported problems across all models
Balt USA LLC · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 18 models of Barricade Coil System by Balt USA LLC in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2018 and Jan 12, 2024 — classified as 2 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 Barricade Coil System problems
Device problems
- Detachment of Device or Device Component6
- Premature Separation5
- Stretched4
- Migration3
- Device Slipped2
- Unraveled Material2
- Activation, Positioning or Separation Problem1
- Difficult or Delayed Positioning1
Patient problems
- Aneurysm15
- No Clinical Signs, Symptoms or Conditions7
- Patient Problem/Medical Problem5
- Death1
- Embolism/Embolus1
Barricade Coil System models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Barricade Coil System 900106Device, Neurovascular Embolization3 reports
- Barricade Coil System 900011Device, Neurovascular Embolization2 reports
- Barricade Coil System 900068Device, Neurovascular Embolization2 reports
- Barricade Coil System 900070Device, Neurovascular Embolization2 reports
- Barricade Coil System 900001Device, Neurovascular Embolization1 report
- Barricade Coil System 900013Device, Neurovascular Embolization1 report
- Barricade Coil System 900039Device, Neurovascular Embolization1 report
- Barricade Coil System 900087Device, Neurovascular Embolization1 report
- Barricade Coil System 900100Device, Neurovascular Embolization1 report
- Barricade Coil System 900104Device, Neurovascular Embolization1 report
- Barricade Coil System 900105Device, Neurovascular Embolization1 report
- Barricade Coil System 900107Device, Neurovascular Embolization1 report
- Barricade Coil System 900108Device, Neurovascular Embolization1 report
- Barricade Coil System 900111Device, Neurovascular Embolization1 report
- Barricade Coil System 900114Device, Neurovascular Embolization1 report
- Barricade Coil System 900116Device, Neurovascular Embolization1 report
- Barricade Coil System 900123Device, Neurovascular Embolization1 report
- Barricade Coil System 900128Device, Neurovascular Embolization1 report
Recent Barricade Coil System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2024Inaccurate Information; Inaccurate Information
IT WAS OBSERVED DURING THE RETURN PROCESS THAT A UNIT FROM BARRICADE COIL FINAL ASSEMBLY PART NO: 300000, PRODUCT 9000390620FL10, LOT F220400512 HAD THE INCORRECT EXPIRATION DATE PRINTED ON THE POUCH LABEL.IS: "2027-04-20"SHOULD BE: "2027-04-23"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18506051 ↗MalfunctionAug 18, 2023No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT: "AT THE MOMENT OF OPENING THE BOX CONTAINING BARRICADE COIL 2X6 THE SECOND BAG WAS OPEN SO THE PRODUCT WAS NOT USED BECAUSE IT HAD LOST ITS STERILIZATION." INCIDENT REPORT FORM RECEIVED FOR THIS COMPLAINT INDICATED NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17572782 ↗MalfunctionAug 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT: "AT THE MOMENT OF OPENING THE BOX CONTAINING BARRICADE COIL 2X4 THE BAG WAS APART FROM THE SHEATH WHICH USUALLY CONTAINS THE COIL, MEANING THAT THE COIL WASN'T STERILE. HOWEVER, THE PRODUCT WAS REMOVED FROM ITS CASE BECAUSE IT WAS AN EMERGENCY AND THERE WERE NO MORE OF THESE PRODUCTS AT THAT TIME. WHEN THE COIL WAS INTRODUCED INTRO THE PATIENT, THE X-RAYS SHOWED THAT THERE WAS NO COIL, ONLY THE CARRIER WIRE WAS PRESENT. AS ONE USUALLY ADVANCES THE COIL UNTIL IT IS SEEN IN THE X-RAYS, AS THERE WAS NONE, IT WAS PUSHED AND THE CARRIER WIRE COLLIDED WITH THE ANEURYSM BUT IT DIDN'T RUPTURE IT." INCIDENT REPORT FORM RECEIVED FOR THIS COMPLAINT INDICATED NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17572780 ↗MalfunctionJan 25, 2022Migration; Premature Separation; Migration; Premature Separation
IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX/AGE: UNKNOWN. LOCATION: M1 DISTAL. PROCEDURE: PLANNED TAE FOR UNRUPTURED ANEURYSM. SIZE OF ANEURYSM: 5×5×5×2MM. MICRO CATHETER: PHENOM17/MEDTRONIC (0.017INCH). <DESCRIPTION> AFTER PLACING 2 COMPETITIVE COILS AND 2 BARRICADE COILS, DURING THE THIRD BARRICADE COIL INSERTION, THE PHYSICIAN FELT RESISTANCE TO OPERATE COIL. THEN THE PHYSICIAN CONTINUED ATTEMPT WITH DOUBLE CATHETER TECHNIQUE(ANOTHER CATHETER WAS SL-10) (THE PHYSICIAN REPEAT ADVANCING AND RETRIEVING COIL FOR THREE TIMES) . THEN THE PHYSICIAN NOTICED THAT THE COIL DID NOT FOLLOW PUSHER WIRE NO LONGER SINCE THE COIL HAS BEEN DETACHED. THEN THEY TRIED TO RETRIEVE THE COIL WITH SNARE, BUT IT FAILED. THE COIL WAS PUSHED INTO DISTAL SIDE OF PARENT ARTERY. ALTHOUGH THE PHYSICIAN CONSIDERED TO PLACE STENT, THEY FINALLY FINISHED PROCEDURE JUST CONFIRMING BLOOD FLOW SINCE THERE WAS THE RISK OF PUSHING THE COIL INTO FURTHER DISTAL OF ARTERY." 05JAN2022 UPDATE - ADDITIONAL INFORMATION RECEIVED FROM ISSUER: "PREMATURE DETACHMENT OF THE IMPLANT OCCURRED IN THE MICROCATHETER, THEN THE IMPLANT FELL INTO THE PARENT ARTERY AFTER THE PHYSICIAN ATTEMPTED TO RETRIEVE THE IMPLANT WITH A SNARE. T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13342917 ↗MalfunctionJul 7, 2021Migration; Premature Separation; Migration; Premature Separation
IT WAS REPORTED THAT: "THE PHYSICIAN WHILE TREATING A RUPTURED LEFT ANTERIOR CHOROIDAL ARTERY ANEURYSM, GOT ACCESS USING 7FR LONG SHEATH AND FARGOMAX 105. ACCESSED THE ANEURYSM WITH VASCO 10 MICROCATHETER AND TRAXCESS WIRE. USED ECLIPSE 2L BALLON AS BACKUP SINCE THE ANEURYSM IS RUPTURED ONE.. AFTER ACCESSING THE ANEURYSM STARTED DEPLOYING COILS. USED 6 BARRICADE COILS OF DIFFERENT SIZES. AFTER THAT TOOK DSA AND FOUND THAT THERE IS SOME MORE SPACE TO BE FILLED FOR GETTING A COMPLETE OCCLUSION OF THE ANEURYSM. SO, THE PHYSICIAN DECIDED TO USE BARRICADE HELICAL FINISH 4 X 10 AS THE LAST COIL. WITHOUT ANY ISSUES THE COIL PASSED THROUGH THE CATHETER INTO THE ANEURYSM. AFTER COUPLE OF LOOPS (ALMOST HALF OF THE LENGTH OF THE COIL) WHILE TRYING TO PUSH THE COIL, THE PHYSICIAN NOTICED THAT THE COIL PUSHER WIRE IS FREELY MOVING, BUT THERE IS NO MOVEMENT TO THE COIL. PHYSICIAN SLOWLY TRIED TO PULL BACK THE PUSHER WIRE AT THAT TIME TOO THE WIRE IS COMING BACK FREELY WITH NO INTERACTION WITH THE COIL AND CONFIRMED THAT THE COIL GOT PREMATURE DETACHMENT WITHIN THE MICRO CATHETER ITSELF. AFTER THAT PHYSICIAN SLOWLY PULLED BACK THE MICRO. WHILE DOING THAT THE ENTIRE COIL MASS WAS ALSO MOVING AND A
Patient problems: Embolism/Embolus
MAUDE report 12128560 ↗MalfunctionFeb 22, 2021Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration
IT WAS REPORTED THAT: "PROCEDURE: COILING. PATHOLOGY: ANEURYSM. ASSOCIATED PRODUCTS: FARGO MINI, VASCO10, CATCH 4*20, VASCO21D, HYBRID, BARRICADE, AXS CATALYST. A BILOBED ACOM ANEURYSM WAS PLANNED FOR TREATMENT BY SIMPLE COILING. 7F/80CM ARROW LONG SHEATH WAS PARKED IN THE LEFT COMMON CAROTID ARTERY. FARGO MINI WAS PARKED INTO PETROUS SEGMENT OF LEFT ICA.VASCO10MP WAS NAVIGATED OVER HYBRID 12 WIRE TO THE ANEURYSM. BARRICADE 6/20 COMPLEX FRAME COIL WAS DEPLOYED FIRST AND DETACHED. BARRICADE 2.5/4 COMPLEX FINISH COIL WAS DEPLOYED IN THE ANEURYSM. MULTIPLE ATTEMPTS WERE MADE TO DETACH THIS COIL BUT COIL DIDN'T DETACH. SO THE OPERATOR DECIDED TO WITHDRAW THE COIL HOWEVER THE COIL DETACHED PREMATURELY AND MIGRATED IN DISTAL ACA. LATER THIS COIL WAS RETRIEVED BY USING CATCH 4/20. AFTER THIS COILING WAS COMPLETED AND CASE WAS UNEVENTFUL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11362967 ↗MalfunctionFeb 16, 2021Device Slipped; Stretched; Detachment of Device or Device Component; Device Slipped; Stretched; Detachment of Device or Device Component
IT WAS REPORTED THAT: "THE CASE WAS AN ACOM ANUERYSM MEASURING 3MMX2.5MM AND HAVING A NECK OF 2.3 MM. SINCE IT WAS A RUPTURED ANUERYSM THE PHYSICIAN PLANNED TO DO A BALLOON ASSISTED COILING. THE SUPPORT HARDWARE WAS NEUROMAX ,FARGOMAX 6F, ECLISPE 6X9 ,VASCO 10 MP WITH HYBRID 12/14 GUIDE WIRE. THE FIRST COIL WAS COMPLEX FINISH 3MMX4MM. THE COIL WAS DEPLOYED WITH BALLOON INFLATION AND THE SECOND COIL WAS COMPLEX FINISH 2MMX3MM AND WHEN HALF A CM OF COIL WAS REMAINING TO BE PUSHED,THE MICRO WAS OUT OF THE ANUERYSM.THE PHYSCIAN WANTED TO WITHDRAW THE COIL IN ORDER TO REPOSITION THE MICRO WITH WIRE AND WHEN HE WAS ATTEMPTING TO WITHDRAW THE COIL IT HAD PREMATURELY DETACHED (NOTE:- NO MANUPILATION WAS DONE TO PUSH THE MICRO WITH THE COIL SUPPORT).NO MOVEMENT OF COIL WAS OBSERVED ON WITHDRAWL OF THE PUSH WIRE THE COIL HAD COME OUT HALF STRECHED ,THE PHYSCIAN USED THE HYBRID 12/14 THROUGH THE VASCO 10 TO ENSURE NO COIL WAS STILL PRESENT IN THE MICRO WITH THE ECLIPSE INFLATED BUT DURING THIS PROCESS SOME PART OF THE COIL CAME INTO THE ACA.THE MICRO AND BALLOON WAS REMOVED. THE PHYSCIAN USED XT 27 AND SOLITAIRE 4X20,CAPTURED THE COIL & REMOVED IT. POST REMOVAL OF THE STRECHED COIL ,THE PHYSC
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11334011 ↗MalfunctionJan 14, 2021Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component
IT WAS REPORTED THAT: "IN THE TREATMENT OF AN ANEURYSM'S BIFURCATION ON A FEMALE PATIENT AGED 60, AFTER THREE ATTEMPTS THE COIL DID NOT DEPLOY SO IT WAS DECIDED TO RETRIEVE IT BUT IT BROKE LEAVING A PART OF IT IN THE VESSEL, THEN IT WAS PUSHED WITH ANOTHER COIL BUT THE PREVIOUS ONE HAD LEFT OCCLUSION IN PART OF THE ARTERY BECAUSE THERE WAS NO CONTROL ON THE BROKEN COIL. DESPITE A BRANCH OF THE VESSEL WAS OCCLUDED IT WAS NOT REPORTED THAT THE PATIENT HAD SIGNIFICANT INJURY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11171849 ↗MalfunctionJul 10, 2020Premature Separation; Premature Separation
IT WAS REPORTED THAT: "THE CASE WAS A CAVERNOUS ICA WIDE NECK ANEURYSM MEASURING 8MMX 7MM AND THE NECK MEASURED 6MM. THE PHYSICIAN PLANNED TO DO A BALLOON ASSISTED COILING OF THE ANEURYSM. THE SUPPORT HARDWARE WAS 7F COOK LONG SHEATH FOLLOWED BY 6F FARGOMAX. THE COPERNIC 5X20 WAS TAKEN ALONG WITH VASCO 10MP WITH HYBRID 12/14 GUIDE WIRE. THE FIRST COIL WAS 9X30 COMPLEX FRAME FOLLOWED BY 8X30 HELICAL FILL COIL. CHECK ANGIO SHOWED ANEURYSM STILL FILLING AND THE PHYSICIAN OPTED TO USE HELICAL FILL 5X20 COIL. THE BALLOON WAS INFLATED AND THE COILING WAS IN PROGRESS DURING WHICH THE PHYSICIAN FELT A SNAP AND SAW THAT THE COIL HAD PREMATURELY DETACHED AND NO MOVEMENT WAS THERE. THE PHYSICIAN DEFLATED THE BALLOON AND TRIED TO GET THE VASCO ALONG WITH COIL BACK INTO THE GUIDE. DURING THIS PROCESS THE COIL CAME PROXIMAL TO GUIDE AND ONLY THE PUSH WIRE CAME OUT. SOME PART OF THE COIL WAS STILL HANGING FROM THE NECK OF THE ANEURYSM AND INTO THE ICA. THE PHYSICIAN OPTED TO LEAVE THE SAME AS IT IS."
Patient problems: Aneurysm
MAUDE report 10259640 ↗MalfunctionMar 14, 2020Premature Separation; Premature Separation
IT WAS REPORTED THAT: "DOCTOR HAD PLANNED TO COIL BASILAR TOP ANEURYSM, AFTER PLACING THE MICROCATHETER, THE DOCTOR TOOK COMPLEX FRAMING 6X20 COIL THROUGH THE MICROCATHETER (VASCO10D MICROCATHETER). AFTER FORMING DESIRED FRAMING THE DOCTOR PUSHED THE COIL FURTHER TO ALIGN WITH THE CATHETER MARKER FOR DETACHING THE COIL, BUT THE COIL DETACHED INSIDE THE MICROCATHETER ITSELF BEFORE EVEN CONNECTING THE DETACHMENT CABLE TO DETACH THE COIL. THE COIL WAS HANGING OUT OF THE ANEURYSM WHICH WAS SNARED OUT IN BITS AND PIECES. COIL WAS COMPLETELY SNARED OUT SO NO INJURY TO THE PATIENT."
Patient problems: Aneurysm
MAUDE report 9832743 ↗MalfunctionJan 14, 2020Premature Separation; Premature Separation
IT WAS REPORTED THAT: "ACOMA ANEURYSM WAS PLANNED USING BARRICADE COILS. VASCO 10 MICRO CATHETER WAS NAVIGATED INTO THE ANEURYSM OVER CHIKAI 14 GUIDE WIRE. FIRST COIL BARRICADE COMPLEX FRAME 4MM/13CMS WAS PREPARED AS PER IFU DEPLOYED AND DETACHED INTO THE ANEURYSM WITHOUT ANY DIFFICULTY. BARRICADE COMPLEX FINISH COIL 3MM/6CMS WAS TAKEN AS SECOND COIL, PREPARED AS PER IFU, THE COIL WAS COMING OUT OF THE ANEURYSM SAC HENCE WAS REPOSITIONED TWICE. WHILE TRYING TO REPOSITION FOR THIRD TIME THE COIL GOT DETACHED INTO THE MICRO CATHETER. THE COIL MIGRATED INTO THE MCA. WHILE ATTEMPTING TO REMOVING THE COIL WITH SOLITAIRE STENT. THE COIL BROKE HALFWAY INTO THE SOLITAIRE AND HALF INTO THE ICA. THE COIL LEFT IN THE ICA WAS PLASTERED WITH ATLAS STENT. NOTHING WAS DONE FURTHER."
Patient problems: Aneurysm
MAUDE report 9589374 ↗MalfunctionNov 4, 2019Positioning Problem
THE PHYSICIAN WAS COILING A 3MM PERI-OPTHALMIC ANEURYSM. HE PLACED A 2.5X17 LVIS AND FRAMED WITH 3X6 CSS. HE THEN PLACED A 3X4 CSS. ON THE 3RD COIL, A 2X6 CSS WAS INTRODUCED WITH THE MICROCATHETER POSITION STILL AT THE DOME OF THE ANEURYSM. THE 2ND LOOP HERNIATED OUT OF THE DOME AND ANGIOGRAPHICALLY APPEARED TO PERFORATE THE ANEURYSM. THE FELLOW PUSHING THE COIL HAD (B)(6) TAKE OVER WHERE HE MOVED THE MC POSITION AND MANIPULATED THE COIL BACK INTO THE ANEURYSM. HE DETACHED THE COIL. POST ANGIO SHOWED CONTRAST IN THE SUB A SPACE AND HE REVERSED HER HEPARIN WITH PROTAMINE. HE THEN WENT INTO THE ICA WITH A SCEPTER BALLOON AND KEPT IT UP FOR SHORT PERIODS OF TIME. POST BALLOON/PROTAMINE SHOWED NO MORE CONTRAST LEAKAGE, AND HE ENDED THE CASE. THE PATIENT WOKE POST ANESTHESIA WITHOUT ANY NEURO DEFICITS. (B)(6) THOUGHT IT WAS THE JAILED MICROCATHETER POSITION THAT CAUSED THE PERFORATION.
Patient problems: Aneurysm
MAUDE report 9273223 ↗MalfunctionSep 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AT PERFORMING A MEDICAL PROCEDURE OF INTRACRANIAL ENDOVASCULAR THERAPY FOR A BRAIN ANEURYSM WHICH WAS BROKEN, THE COIL BARRICADE 4X13 DEPLOYED BY ITSELF. IF STRETCHED AND GOT THIN. SO, THE DEPLOYED PART STAYED IN THE ANEURYSM AND CAROTID. THE PART OF THE STENT WHICH WAS POSSIBLE TO RECOVER WAS SENT BACK TO THE DISTRIBUTOR SO THAT THEY ASK THE MANUFACTURER FOR THE REGARDING ANALYSIS. AFTER THE INCIDENT A STENT WAS IMPLANTED IN ORDER TO FIX THE COIL WHICH STAYED IN THE CAROTID. FOLLOW UP SENT (8/23/2019): "DID THE DEVICE DETACH BEFORE OR AFTER A DETACHMENT CYCLE WAS INITIATED?.IT STATED THAT PART OF THE COIL STAYED IN THE ANEURYSM. DID THE COIL BREAK? WHY WAS THIS REPORTED TO INVIMA? WAS IT REPORTED BY THE HOSPITAL OR BY C.I. DISMECOL? WHAT OCCURRED WITH THE STENT?" FOLLOW UP RECEIVED (8/30/2019): " IT WAS BEFORE A DETACHMENT CYCLE WAS INITIATED. YES, THE COIL BROKE IT WAS REPORTED TO INVIMA BY THE INSTITUTION BECAUSE ACCORDING TO THEIR PROTOCOLS THEY HAD TO. IT WAS THE PHARMACEUTICAL CHEMIST'S DECISION. THE COIL STAYED PRESSED TO THE ARTERY'S WALL. THAT'S WHY IT WAS NECESSARY TO USE A STENT IN ORDER TO AVOID IT TO STAY FLOATING AND THAT IT MIGHT MIGRATE." FOLLOW UP SENT (9/4/2019):
Patient problems: Aneurysm
MAUDE report 9099062 ↗MalfunctionJul 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT: "DR. (B)(6) (INR) DECIDED TO DO A STENT ASSISTED COILING CASE OF ACOM ANEURYSM WITH OUR COILS. HE USED PCONUS DEVICE IN THIS CASE. FIRST TWO COILS HE DEPLOYED WERE BARRICADE COMPLAX FRAME 11-7 AND 8-27 AND THIS WAS THE THIRD COIL WHICH HE WAS DEPLOYING. IT WENT WELL IN THE MICRO CATHETER BUT IN SIDE THE ANEURYSM IT WAS NOT BEHAVING WELL SO PHYSICIAN DECIDED TO REPOSITION IT , WHILE TAKING OUT THE COIL FROM ANEURYSM, IT GET DETACHED AND ALMOST MORE THEN HALF OF THE COIL WAS OUT SIDE THE ANEURYSM. FURTHER, HE RETRIEVED THIS COIL WITH THE HELP OF SNARE AND DEPLOYED MICROPLEX COILS. HE WAS SURPRISED TO SEE THAT WITHOUT DETACHMENT HOW THE COIL CAN GET DETACHED. FINALLY HE COMPLETED THE PROCEDURE."
Patient problems: Aneurysm
MAUDE report 8753936 ↗MalfunctionJun 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT: "PROCEDURE - ANEURYSM COILING, PATHOLOGY - ACOM ANEURYSM, ACCESSORIES - VASCO 10 MH-MP, ECLIPSE 9. DURING AN ANEURYSM COILING CASE WITH BALLOON ASSISTANCE, BARRICADE HELICAL FINISH COIL 1X3 WAS TAKEN FOR DEPLOYMENT. COIL WAS PREPARED AS PER THE IFU & INTRODUCED INTO Y-ADAPTOR FOR FLUSH. SHRINK LOCK WAS REMOVED & COIL PUSH-WIRE WAS ADVANCED TO PUSH COIL THROUGH Y-ADAPTOR INTO MICRO-CATHETER FOR DEPLOYMENT. COIL WAS DEPLOYED IN ACOM ANEURYSM; HOWEVER, IT WAS NOT SATISFACTORY, SO PHYSICIAN RETRIEVED & AGAIN ATTEMPTED DEPLOYMENT. WHILE 1.5-2 CM COIL LENGTH WAS INSIDE ANEURYSM SUDDENLY CONTROL ON COIL PUSH WIRE WAS LOST. IT WAS OBSERVED THAT COIL HAD DETACHED PREMATURELY INSIDE THE MICRO CATHETER WITH APPROXIMATELY 1CM COIL LENGTH IN IT. AFTER SOME MANIPULATION COIL WAS PUSHED INTO ANEURYSM WITH HELP OF COIL PUSH WIRE, BUT PROXIMAL LOOPS WERE HANGING IN PARENT VESSEL. AFTER SOME TIME, COIL MOVED & GOT MISPLACED. IT WAS RETRIEVED SUCCESSFULLY WITH STENT RETRIEVER. CASE WAS COMPLETED BY PLACING ANOTHER COIL (COMPLEX FINISH 1.5X2) FOLLOWED BY IMPLANTING BABY LEO 2.5X25."
Patient problems: Aneurysm; Patient Problem/Medical Problem
MAUDE report 8710126 ↗
Other Balt USA LLC products
All Balt USA LLC devices →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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