Optima Coil SystemRecalls & reported problems across all models
Balt USA LLC · 379 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one Optima Coil System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 182
- Deaths reported
- 2
- Injuries reported
- 15
- Recalls
- 6
We found 379 models of Optima Coil System by Balt USA LLC in the FDA's device registry (GUDID). Together they are named in 182 adverse event reports in the FDA's MAUDE database, received between Nov 5, 2018 and Aug 27, 2026 — classified as 2 deaths, 15 injuries, 165 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (87 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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
Optima Coil System 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.
- May 8, 2025Open, Classified
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Z-1988-2025 · Root cause: Vendor change control · names 84 of these models · Recall details · FDA record ↗
- Jan 3, 2024Open, Classified
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
Z-1042-2024 · Root cause: Material/Component Contamination · names 27 of these models · Recall details · FDA record ↗
- Jan 3, 2024Open, Classified
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
Z-1041-2024 · Root cause: Material/Component Contamination · names 327 of these models · Recall details · FDA record ↗
- Sep 7, 2022Open, Classified
Product pouch label does not match up with carton label
Z-0103-2023 · Root cause: Error in labeling · names 2 of these models · Recall details · FDA record ↗
- Jul 26, 2022Open, Classified
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Z-1680-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 4, 2022Open, Classified
Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.
Z-0660-2022 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported Optima Coil System problems
Device problems
- Premature Separation87
- Migration47
- Stretched32
- Detachment of Device or Device Component13
- Separation Problem8
- Expulsion7
- Insufficient Device Problem Information7
- Fracture4
Patient problems
- No Clinical Signs, Symptoms or Conditions143
- Aneurysm23
- Rupture7
- Patient Problem/Medical Problem6
- Insufficient Information2
- Ischemia Stroke2
- Paralysis2
- Ruptured Aneurysm2
Optima Coil System models
379 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Optima Coil System OPTI0208CSS10Device, Neurovascular Embolization3 recalls3 reports
- Optima Coil System OPTI0308CSS10Device, Neurovascular Embolization2 recalls6 reports
- Optima Coil System OPTI0720CSFMXDevice, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0930CSFMXDevice, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXDevice, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0203CSS10Device, Neurovascular Embolization2 recalls3 reports
- Optima Coil System OPTI0256CSS10Device, Neurovascular Embolization2 recalls3 reports
- Optima Coil System OPTI0410CSS10Device, Neurovascular Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSF10Device, Neurovascular Embolization2 recalls3 reports
- Optima Coil System OPTI0407CSFMXDevice, Vascular, For Promoting Embolization2 recalls2 reports
- Optima Coil System OPTI4510CSFMXDevice, Vascular, For Promoting Embolization2 recalls2 reports
- Optima Coil System OPTI0102CSS10Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0103CSS10Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0206CSS10Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0310CSS10Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0513CSS10Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0407CSF10Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0827CSF10Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0923CST10Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0202CSSMXDevice, Vascular, For Promoting Embolization2 recalls1 report
- Optima Coil System OPTI0307CSSMXDevice, Vascular, For Promoting Embolization2 recalls1 report
- Optima Coil System OPTI0310CSSMXDevice, Vascular, For Promoting Embolization2 recalls1 report
- Optima Coil System OPTI0510CSFMXDevice, Vascular, For Promoting Embolization2 recalls1 report
- Optima Coil System OPTI1040CSFMXDevice, Vascular, For Promoting Embolization2 recalls1 report
- Optima Coil System OPTI1650CSFMXDevice, Vascular, For Promoting Embolization2 recalls1 report
- Optima Coil System OPTI0154CSS10Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0509CSF10Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0517CSF10Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0520CSF10Device, Vascular, For Promoting Embolization2 recalls1 report
- Optima Coil System OPTI0611CSF10Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0724CSF10Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0923CST10Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0204HSS10Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0208HSS10Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0102CSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0206CSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0256CSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0410CSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0611CSF10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0724COM18Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0930COM18Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1034COM18Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1550COM18Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0103HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0152HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0202HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0204HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0408HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0255CSSMXDevice, Vascular, For Promoting Embolization2 recalls0 reports
- Optima Coil System OPTI3535CSSMXDevice, Vascular, For Promoting Embolization2 recalls0 reports
- Optima Coil System OPTI0404CSFMXDevice, Vascular, For Promoting Embolization2 recalls0 reports
- Optima Coil System OPTI4545CSFMXDevice, Vascular, For Promoting Embolization2 recalls0 reports
- Optima Coil System OPTI0507CSFMXDevice, Vascular, For Promoting Embolization2 recalls0 reports
- Optima Coil System OPTI0715CSFMXDevice, Vascular, For Promoting Embolization2 recalls0 reports
- Optima Coil System OPTI1245CSFMXDevice, Vascular, For Promoting Embolization2 recalls0 reports
- Optima Coil System OPTI1445CSFMXDevice, Vascular, For Promoting Embolization2 recalls0 reports
- Optima Coil System OPTI0153HSSMXDevice, Vascular, For Promoting Embolization2 recalls0 reports
- Optima Coil System OPTI0101CSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0304CSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0358CSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0204CSF10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0206CSF10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0208CSF10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0308CSF10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0310CSF10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0724COM18Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0930COM18Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1034COM18Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1137COM18Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1550COM18Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0103HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0104HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0151HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0152HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0153HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0202HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0256HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0308HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0408HSS10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1030HST10Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0620CSFMXDevice, Vascular, For Promoting Embolization1 recall6 reports
- Optima Coil System OPTI0152CSSMXDevice, Vascular, For Promoting Embolization1 recall4 reports
- Optima Coil System OPTI0517CSFMXDevice, Vascular, For Promoting Embolization1 recall4 reports
- Optima Coil System OPTI0615CSFMXDevice, Vascular, For Promoting Embolization1 recall4 reports
- Optima Coil System OPTI0830CSFMXDevice, Vascular, For Promoting Embolization1 recall3 reports
- Optima Coil System OPTI0152CSS10Device, Neurovascular Embolization1 recall3 reports
- Optima Coil System OPTI0306CSS10Device, Neurovascular Embolization1 recall3 reports
- Optima Coil System OPTI0408CSS10Device, Neurovascular Embolization1 recall3 reports
- Optima Coil System OPTI2065COM18Device, Neurovascular Embolization1 recall3 reports
- Optima Coil System OPTI0204CSS10Device, Neurovascular Embolization1 recall2 reports
- Optima Coil System OPTI0254CSS10Device, Neurovascular Embolization1 recall2 reports
- Optima Coil System OPTI0308CSS10Device, Neurovascular Embolization1 recall2 reports
- Optima Coil System OPTI0408CSS10Device, Neurovascular Embolization1 recall2 reports
- Optima Coil System OPTI0620CST10Device, Neurovascular Embolization1 recall2 reports
- Optima Coil System OPTI2525CSSMXDevice, Vascular, For Promoting Embolization1 recall1 death2 reports
- Optima Coil System OPTI0611CSFMXDevice, Vascular, For Promoting Embolization1 recall2 reports
- Optima Coil System OPTI0254CSS10Device, Neurovascular Embolization1 recall2 reports
- Optima Coil System OPTI0615CSF10Device, Vascular, For Promoting Embolization1 recall2 reports
- Optima Coil System OPTI0620CST10Device, Neurovascular Embolization1 recall2 reports
- Optima Coil System OPTI0103BLKDevice, Vascular, For Promoting Embolization1 recall1 report
Recent Optima Coil System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Migration; Premature Separation
It was reported that:" During a coil embolization of bi-lateral MMA for Csdh, the physician attempted to deploy his last coil an OptiBLOCK 2x12 coil through a Sl-10 Microcatheter. As he advanced the coil he attempted to reposition and lost 1 to 1 and it was observed that the coil was no longer attached to delivery wire. He attempted to use delivery wire and a Synchro wire to push the remainder of the coil out of SL-10. This was noted to be difficult and he had to leave a long coil tail into the Maxillary.Coil was prepped per DFU. No patient injury occurred. " Incident Report Form submitted for this complaint indicates that no patient injury was sustained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476904 ↗InjuryJul 27, 2026Separation Problem
It was reported that:"The Physician planned to treat Acom Aneurysm and primed the Vasco 10 Micro catheter after Prechecked the Optima Complex 4.5x10 coil he placed it inside the aneurysm and tried to detach the coil. After Multiple attempts and tried all the techniques the coil didn't detach so he tried to resheath the coil into the micro catheter the coil got detached halfway into the fargo guiding catheter. The Physician Removed the coil by aspirating and used another Optima to Finish the Procedure."UPDATE 29JUN2026 - Additional information received from the issuer:"1. the vessel was torturous.2. The Detacher, Micro catheter is not available for return.3. Precheck was performed on the coil.4. the Xcel showed red and green light when the Physician was ready to detach. We tried rotating the Xcel, wiping the detachment gold marker end, still red and green light was blinking."Incident Report Form submitted for this complaint indicates that no patient injury was sustained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015103 ↗MalfunctionJul 2, 2026Separation Problem
IT WAS REPORTED THAT: "- DURING THE PROCESS OF PUSH "5 X 17 CST" INTO ANEURYSM, THE ANEURYSM WAS RUPTURED. - SO, USER ATTEMPTED TO FORM A FRAME WITH "5 X 17 CST" SEVERAL TIMES, THE COIL WAS DETACHED. - ACCORDING TO THE MENTION OF ASSISTANT, THE PROCEDURE WAS SIGNIFICANTLY DELAYED DUE TO REMOVE THE COIL. - THE USER CONSIDERED, BECAUSE THE USER TRIED FRAME PROCEDURE WITH SOME TENSION, THE PRE-DETACH CAME OUT. - THE USER DID NOT COMPLAIN SO MUCH AT THIS TIME, BUT WE HAVE SAME ISSUE ALREADY (3RD APRIL), WE ARE REQUIRED TO CONSIDER ABOUT PRE-DETACH ISSUE OF 5X17CST WHICH HAS SAME LOT NUMBER AND SIZE." UPDATE 15JUN2026 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. WOULD YOU BE ABLE TO CONFIRM IF OUR UNDERSTANDING IS CORRECT: A. THE PHYSICIAN WAS ATTEMPTING TO EMBOLIZE THE ANEURYSM AND DURING THE ATTEMPT TO PUSH THE OPTI0517CST10 TO THE TREATMENT LOCATION, THEY RUPTURED THE ANEURYSM? NO. 2. THE COMPLAINT DESCRIPTION STATES "THE PROCEDURE WAS SIGNIFICANTLY DELAYED DUE TO REMOVE THE COIL" HOW DID THE PHYSICIAN REMOVE THE COIL? A. WHERE DID THE IMPLANT PREMATURELY DETACH? (INSIDE THE ANEURYSM, OR MICROCATHETER, ETC)- M/C. 3. HOW WOULD THE TORTUOSITY OF THE ANATOMY BE DESCRIBED? N/A.
Patient problems: Ruptured Aneurysm
MAUDE report 25692940 ↗MalfunctionJul 2, 2026Premature Separation
IT WAS REPORTED THAT: "1. THE FIRST MANEUVER WITH THE 1.5F FLOW DIRECTED CATHETER AND HYBRID008 WAS SMOOTH. THE SECOND MANEUVER RESULTED IN THE HYBRID GETTING STUCK IN THE CATHETER. 2. THE OPTIMA COIL COMPLEX 12X40 WAS PUSHED INTO THE DELIVERY CATHETER WITH AN INTERNAL DIAMETER OF 0.017 INCHES. THE COIL THEN DETACHED SPONTANEOUSLY. FORTUNATELY, THE COIL CAN BE RETRIEVED WITH A SNARE." UPDATE 10JUN2026 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. DID THE PROCEDURE INVOLVE TORTUOUS ANATOMY? YES, THE ACCESS THROUGH A VEIN AND THE TARGET WAS A RIGHT CAVERNOUS SINUS (INDIRECT CCF CASE). HOWEVER, ON THE LEFT SIDE, ANOTHER COIL BRAND WAS SUCCESFULLY DEPLOYED. 2. WILL THE MICROCATHETER BE AVAILABLE FOR RETURN? NO, WE USED THE HEADWAY 17 MICROCATHETER. 3. WHERE DID THE IMPLANT PREMATURELY DETACH? (INSIDE THE AN, INSIDE THE MC? ETC) THE OPTIMA COIL HAS JUST DEPLOYED TWO LOOPS IN THE FISTULA, NOT THE ANEURYSM. THEN, WE CAN'T PUSH THE COIL FURTHER DUE TO IT DETACHING ITSELF (SEE ATTACHED IMAGE). 4. WERE ANY ATTEMPTS MADE TO DETACH THE IMPLANT COIL USING THE DETACHMENT CONTROLLER? NO. 5. CAN YOU CONFIRM IF THE DEVICE WAS IMPLANTED? AFTER THE COIL DETACHED AND BROKE DOWN IN THE NORMAL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25692094 ↗MalfunctionJun 12, 2026Premature Separation
IT WAS REPORTED THAT: "PHYSICIAN WAS COILING THE HOLE OF A CC FISTULA AND WENT UP WITH A OPTIBLOCK 3X30 DURING DEPLOYMENT THE PHYSICIAN WENT TO REPOSITION HIS MICROCATHETER SO HE PULLED THE COIL BACK AS IT WAS STILL BEING DEPLOYED AND THEN THE COIL SNAPPED INSIDE THE MICROCATHETER WITH SOME OF IT LEFT IN THE FISTULA HOLE. THEY WERE ABLE TO USE A BALLOON AS A SNARE TO TRAP THE LOOSE COIL AGAINST THE SIDE OF THE MICROCATHETER AND REMOVE IT FROM THE PATIENT VESSEL." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488954 ↗MalfunctionMay 29, 2026Migration
IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING A RUPTURED RIGHT PCOM ANEURYSM. SHE WAS ABLE TO SUCCESSFULLY DEPLOY A 4X7 OPTIMAX. SHE FOLLOWED WITH A 2X4 OPTIMAX. SHE WAS ABLE TO POSITION THE COIL AFTER ATTEMPTING MULTIPLE ADJUSTMENTS PULLING/PUSHING TO FIND THE RIGHT PLACEMENT. SHE RECEIVED A SUCCESSFUL GREEN LIGHT SEQUENCE ON THE DETACHER. SHE SLOWLY PULLED BACK THE PUSHER WIRE FROM THE COIL MASS UNTIL THE WIRE WAS NO LONGER VISIBLE ON THE SCREEN WHEN THE TAIL OF THE COIL GOT SUCKED INTO THE MICROCATHETER. SHE USED THE PUSHER WIRE TO REPOSITION THE COIL AND TUCK IT BACK INTO THE MASS THEN STARTED PULLING BACK ONCE AGAIN. AGAIN, THE PUSHER WIRE WAS OFF THE SCREEN WHEN THE COIL SUCKED BACK INTO THE MICRO. SHE THEN ADVANCED THE MICRO AND GUIDEWIRE AT THE SAME TIME WHICH FREED THE COIL; HOWEVER, IT DISPLACED THE LAST LOOP AND IT MOVED INTO THE ICA. SHE TRIED ONCE AGAIN TO PUSH THE TAIL BACK INTO THE COIL MASS USING THE GUIDEWIRE AND MICRO WHICH ENDED UP FURTHER KICKING THE TAIL INTO THE ICA. SHE WAS WORRIED ABOUT THE COIL FLYING AWAY AND DECIDED TO STENT DOWN THE COIL TAIL. NO FURTHER COILS WERE DEPLOYED. SHE USED A 45 DEGREE SL10 AS THE MICRO." UPDATE 01MAY2026 - ADDITIONAL INFOR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333034 ↗MalfunctionMay 29, 2026Premature Separation
IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING A BILATERAL MMA. SHE WAS COILING PROXIMALLY AND WAS DEPLOYING A 3X30 OPTIBLOCK. SHE DIDN'T LIKE THE WAY IT WAS TRACKING SO SHE GENTLY PULLED BACK ON THE COIL AND IT BROKE. SHE USED A 3MM TREEVO TO CAPTURE THE COIL AND PROCEEDED WITH THE PROCEDURE. I HAD PLANNED ON RETURNING THE COIL BUT THE STAFF THREW IT AWAY WHILE I WAS GRABBING ADDITIONAL COILS FOR THE CASE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332944 ↗MalfunctionMay 29, 2026Migration; Premature Separation
IT WAS REPORTED THAT: "DURING EMBOLIZATION OF AN ACOM ANEURYSM, THE PHYSICIAN POSITIONED AN SL-10 MICROCATHETER WITHIN THE ANEURYSM AND REQUESTED AN OPTIMAX SS 1.5 X 2 COIL. AS THE COIL WAS ADVANCED THROUGH THE MICROCATHETER, IT WAS VISUALIZED UNDER FLUOROSCOPY WITHIN THE CATHETER. HOWEVER, UPON ADVANCING THE FINAL QUARTER OF THE COIL INTO THE ANEURYSM, LOSS OF ONE-TO-ONE RESPONSE OCCURRED, AND THE COIL COULD NEITHER BE ADVANCED NOR RETRACTED. USING THE DELIVERY WIRE, THE PHYSICIAN WAS ABLE TO ADVANCE THE REMAINING PORTION OF THE COIL INTO THE ANEURYSM. FOLLOW-UP IMAGING DEMONSTRATED THE 1.5 X 2 OPTIMAX COIL POSITIONED AT THE ANEURYSM NECK AND WITHIN THE ACOM. ON SUBSEQUENT IMAGING, THE COIL HAD MIGRATED INTO THE A2 SEGMENT. THE DELIVERY WIRE WAS REMOVED, AND THE SL-10 MICROCATHETER WAS WITHDRAWN. THE PHYSICIAN URGENTLY REQUESTED A TREVO RETRIEVAL SYSTEM, INCLUDING A TRAK 21 MICROCATHETER AND TREVO STENT RETRIEVER. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE MIGRATED COIL, DURING WHICH THE COIL CONTINUED TO MOVE DISTALLY. AFTER THREE PASSES, SUCCESSFUL RETRIEVAL WAS ACHIEVED USING A LARGER TREVO STENT RETRIEVER. THE COIL WAS PREPARED ACCORDING TO THE DFU. THE DELIVERY WIRE AND COIL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332925 ↗MalfunctionMay 22, 2026Migration; Separation Problem
IT WAS REPORTED THAT: "THE PHYSICIAN FRAMED WITH A 7X20 MAX DURING HIS ANEURYSM TREATMENT AND ATTEMPTED TO DETACH, WHILE RECEIVING A REPETITIVE GREEN LIGHT ON THE XCEL THE COIL WOULDN'T PROPERLY DETACH. ONCE HE WAS TRYING TO REMOVE THE COIL AFTER IT WOULDN'T DETACH THE COIL DETACHED HALFWAY OUT OF THE ANEURYSM/HALFWAY IN THE PARENT ARTERY. HE WAS ABLE TO PUSH THE COIL BACK IN THE ANEUSYM WITH THE PUSHER WIRE BUT THE FRAMING WASN'T IDEAL. TWO COILS LATER DURING HIS FILLING PORTION A COIL WAS VERY STICKY AND HAD A SIMILAR DETACHMENT ISSUE WITH RECEIVING A GREEN LIGHT BUT WOULDN'T DETACH FROM PUSHER. COIL ULTIMATELY DETACHED AFTER MANIPULATING FOR A WHILE...BOTH PUSHER WIRES ARE SAVE AND WILL BE RETURNED. LASTLY, HE SAID HE USUALLY DOESN'T DO CAPITAL T IN THE DETACHMENT ZONE. CLOSER TO A LOWER-CASE T" UPDATE (B)(6) 2026 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. THE ANATOMY WAS NOT TORTUROUS. PHYSICIAN SAID, "STRAIGHT SHOT INTO THE BASILAR". 2. XCEL & MC WAS NOT SAVED. 3. THEY PRE-CHECKED THE COILS SHOWING GREEN. 4. THE XCEL WAS SHOWING GREEN BUT WOULD NOT DETACH. HE NEVER RECEIVED A RED/GREEN". INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT IN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25261901 ↗MalfunctionMay 14, 2026Premature Separation
IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING AN AVM ON A 3.5-YEAR-OLD PATIENT. HE TREATED THE FEEDING VESSEL WITH 3 OPTIBLOCK MINI COILS AND HAD A GREAT RESULT. HE PERFORMS RESEARCH AND TAKES A COIL AND MOVES IT AROUND IN THE AREA OF THE AVM SO HE CAN TAKE THE CELLS AND DO TESTING FOR RESEARCH. UNFORTUNATELY, WHILE HE WAS ALLOWING THE COIL TO MOVE INSIDE THE AVM, THE COIL DETACHED. PHYSICIAN UNDERSTANDS IT MAY BE DUE TO THE STRESS THAT WAS PUT ON THE COIL. HE WAS ABLE TO SNARE THE COIL AND DID NOT CAUSE ANY NEGATIVE HARM TO PATIENT AND WAS ABLE TO RESUME CASE SUCCESSFULLY. USED A HEADWAY DUO 167 MICRO." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174428 ↗MalfunctionMay 14, 2026Premature Separation
IT WAS REPORTED THAT: "DURING A COIL EMBOLIZATION OF MMA FOR CSDH, THE PHYSICIAN ATTEMPTED TO DEPLOY OPTIBLOCK 2X20 COIL THROUGH A SL-10 MICROCATHETER. THE COIL PUSHED BACK THE SL-10 AS IT WAS ADVANCED OUT OF DISTAL END. THE PHYSICIAN RESHEATHED COIL AND REPOSITIONED MICRO MORE DISTAL. HE THEN RELOADED THE OPTIBLOCK 2X20 COIL AND AFTER DEPLOYING THE FIRST TWO LOOPS OF COIL HE LOST 1 TO 1 AND IT WAS OBSERVED THAT THE COIL WAS NO LONGER ATTACHED TO DELIVERY WIRE. HE USED A SYNCHRO WIRE TO PUSH THE REMAINDER OF THE COIL OUT OF SL-10. THIS WAS NOTED TO BE DIFFICULT BUT THE ENTIRE COIL WAS ULTIMATELY PUSHED INTO VESSEL. COIL WAS PREPPED PER DFU. NO PATIENT INJURY OCCURRED. THE DELIVERY WIRE IS AVAILABLE FOR RETURN." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174268 ↗MalfunctionMay 8, 2026Migration; Premature Separation
IT WAS REPORTED THAT: "I WAS INFORMED BY THE PHYSICIAN THAT THIS PARTICULAR COIL BROKE IN HALF WHILE ATTEMPTING TO REMOVE FROM FRAMING A SAH. THE PROXIMAL PART OF THE COIL FLOATED INTO THE PARENT ARTERY AND REQUIRED A STENT. WHILE TAKING THE COIL OUT OF THE HOOP THEY NOTICED THE COIL WAS EXPOSED FROM THE SHEATH. NOTHING OUT OF THE ORDINARY WAS DONE BY THE PHYSICIAN TO CAUSE THIS TO HAPPEN, ANATOMY WAS ALSO STRAIGHT FORWARD. THEY DID NOT KEEP THE PUSHER WIRE TO RETURN THE PRODUCT." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125184 ↗MalfunctionMay 7, 2026Migration
IT WAS REPORTED THAT: "PHYSICIAN DEPLOYED THE OPTIMAX 4X7 IN AN ANEURYSM TO FRAME. A VERY STRAIT TAIL POPPED OUT THROUGH THE STENT STRUTS AND INTO THE PARENT VESSEL. HE THEN DEPLOYED AN OPTIMA HELICAL 3X6 SS AND A TAIL REMNANT WAS STICKING OUT AS WELL. HE HAD TO PLACE A 2ND STENT TO TACK IT UP. THE PHYSICIAN SAID IT HAS HAPPENED MORE THAN A FEW TIMES WITH BALT COILS." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113971 ↗MalfunctionMay 7, 2026Migration
IT WAS REPORTED THAT: "PHYSICIAN DEPLOYED THE OPTIMAX 4X7 IN AN ANEURYSM TO FRAME. A VERY STRAIT TAIL POPPED OUT THROUGH THE STENT STRUTS AND INTO THE PARENT VESSEL. HE THEN DEPLOYED AN OPTIMA HELICAL 3X6 SS AND A TAIL REMNANT WAS STICKING OUT AS WELL. HE HAD TO PLACE A 2ND STENT TO TACK IT UP. THE PHYSICIAN SAID IT HAS HAPPENED MORE THAN A FEW TIMES WITH BALT COILS." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113910 ↗MalfunctionApr 30, 2026Premature Separation
IT WAS REPORTED THAT: "COIL LOST ITS 1 TO1 PUSH/PULL FEEL DR. COULD NOT REMOVE COIL WHILE FINISHING 5-10CM REMAINED IN CATH DETATCHED WITH CATHETER AND PUSHED REMAINING COIL OUT WITH .014 MICROWIRE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25052657 ↗
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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