Optima Coil System OPTI0308CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818053025891), received between Feb 16, 2021 and May 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K172390); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

2. Sep 7, 2022Open, Classified

   Product pouch label does not match up with carton label

   Z-0103-2023 · Root cause: Error in labeling · FDA record ↗

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.

• MalfunctionMay 16, 2025Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN PLANNED TO DO A PCOM ANEURYSM CASE. THE PLAN WAS TO USE OPTIMA COILS. AFTER GETTING ACCESS TO THE ANEURYSM TOOK OPTIMA COMPLEX SOFT 4X13AND FOLLOWED WITH OPTIMA COMPLEX SS 3X8. THE PHYSICIAN PACKING THE OPTIMA COMPLEX SS 3X8 COIL AND SOMEMOVENT COIL NO MOVEMENT PREMATURELY DETACHED AND COIL MIGRATED TO THE ICA BIFURCATION. THE PHYSICIAN TRYING TO OUT PREMATURE COIL BUT HE FACING SOME DIFFICULTIES AND AFTER THAT THE PHYSICIAN USED STENTRETRIVER AND REMOVED THE COIL.THE PHYSICIAN TOOK ANOTHER OPTIMA COIL FINISHED THE CASE. THE CASE WENT OFF WELL AND THE PATIENT IS DOING FINE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. UPDATE 22APR2025- ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. DID THE PROCEDURE INVOLVE TORTUOUS ANATOMY? NO 2. WILL THE MICROCATHETER BE AVAILABLE FOR RETURN? NO 3. WHERE DID THE IMPLANT PREMATURELY DETACH? (INSIDE THE AN, INSIDE THE MC?, ETC) PARTIALLY DEPLOYED IN THE COIL ANEURYSM AND ONE LOOP CAME OUT AND PHYSICIAN TRYING TO PULL BACK NO MOVEMENT. 4. WERE ANY ATTEMPTS MADE TO DETACH THE IMPLANT COIL USING THE DETACHMENT CONTROLLER? NO 5. CAN YOU CONFIRM IF THE DEVIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038663 ↗
• MalfunctionApr 24, 2024Nonstandard Device; Nonstandard Device

  ON MARCH 18TH, A COMPLAINT WAS RECEIVED FROM A CUSTOMER INDICATING THAT THEY ENCOUNTERED VISIBILITY ISSUES DURING THE USE OF AN OPTIMA COIL SYSTEM WHEN ATTEMPTING TO VISUALIZE THE RO COIL COMPONENT OF THE DELIVERY PUSHER UNDER FLUOROSCOPIC GUIDANCE. THIS WAS THE 5TH COMPLAINT THROUGH 2024 WHICH WAS RECEIVED FOR THIS SAME ISSUE, AND UPON ADDITIONAL INVESTIGATION, IT WAS DISCOVERED THAT THE SAME HYPOCOIL SUBASSEMBLY LOT NUMBER WAS USED IN THE MANUFACTURING OF THESE UNITS. THIS HYPOCOIL SUBASSEMBLY LOT (S221000089) WAS MANUFACTURED BY AN EXTERNAL SUPPLIER ACCORDING TO THE MANUFACTURING RECORDS. TO DATE, ALL COMPLAINT CASES INVOLVING VISIBILITY ISSUES FROM THIS HYPOCOIL SUBASSEMBLY LOT NUMBER HAVE RESULTED IN NO PATIENT HARM AND REQUIRED THE USER TO REPLACE THE UNIT WITH A NEW COIL SYSTEM TO COMPLETE THE PROCEDURE. DUE TO THE SIMILARITY IN SUBASSEMBLY LOT NUMBER, TWO OF THESE COMPLAINT UNIT SAMPLES WERE SENT FOR MATERIAL ANALYSIS TO AN EXTERNAL VENDOR. ON 29MAR2024, THE RESULTS OF THIS THIRD-PARTY MATERIAL ANALYSIS WAS RECEIVED WHICH REVEALED THAT THE IMPLICATED SECTION WHERE THE PURPORTED RO COIL WOULD BE WELDED TO THE SSTL PORTION OF THE DEVICE WAS IN-FACT NOT THE INTENDED COIL WIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176982 ↗
• MalfunctionOct 25, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN HAD A PREMATURE DETACHMENT OF AN OPTIMA 3MM X 8CM. USING AN SL-10 95 DEGREE MICROCATHETER, THE PHYSICIAN DEPLOYED 2 COILS INTO A 6MM PCOM ANEURYSM (ONE 6X15CM ORBIT AND ONE 5X10CM OPTIMA CSS). FOR THE 3RD COIL, THE PHYSICIAN PREPPED OUR 3X8 CSS PER DFU AND ADVANCED THROUGH CATHETER WITHOUT ISSUE. SINCE THE COIL DID NOT SIT AS HE NEEDED, THE PHYSICIAN TRIED REPOSITIONING THE 3X8 OPTIMA CSS AND UPON REPOSITIONING, IT PREMATURELY DETACHED. HE FORTUNATELY HAD ENOUGH OF THE COIL IN THE MICROCATHETER THAT ALLOWED HIM TO SAFELY PULL THE MICROCATHETER OUT OF THE BODY. AS THEY PULLED THE MICROCATHETER OUT, A SMALL LOOP OF THE PREVOIUS COIL HERNIATED OUT OF THE ANEURYSM. THEY FELT CONFIDENT THAT THIS SMALL LOOP WOULD NOT POSE A SAFETY RISK. THE CONCLUDED THE CASE WITH A TOTAL OF JUST TWO COILS IMPLANTED. NO PATIENT INJURY OCCURED DURING PROCEDURE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003348 ↗
• MalfunctionAug 18, 2023Device Contaminated at the User Facility; Device Contaminated at the User Facility

  IT WAS REPORTED THAT: "THERE WAS FOREIGN MATTER INSIDE THE COIL SHEATH" INCIDENT REPORT FORM RECEIVED FOR THIS COMPLAINT INDICATED NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572764 ↗
• MalfunctionJan 25, 2022Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "AFTER INSERTING THE COIL, THE SHAPE AND LOCATION WERE UNSATISFACTORY, SO RECAPTURE WAS TRIED TWICE. WHEN RECAPTURE WAS TRIED AGAIN, THE COIL DID NOT MOVE. WHEN CHECKED IT WAS FOUND THAT IT WAS PRE-DETACHED." 05JAN2022 UPDATE - ADDITIONAL INFORMATION RECEIVED FROM ISSUER: "DURING DEPLOYMENT OF THE COMPLEX SUPER SOFT 3X8 COIL, THE LOOP KEPT COMING OUT OF THE ANEURYSM. THE MICROCATHETER WAS INSERTED IN AND OUT 3 TIMES. THE COIL DID NOT MOVE, AND WHEN CHECKED, IT WAS FOUND TO BE PRE-DETACHED. THE COIL WAS LEFT INSIDE THE MICROCATHETER. THE PUSHER WIRE OF THE COIL WAS USED TO PUSH THE COIL THAT WAS INSIDE THE MICROCATHETER INTO THE ANEURYSM. THE COIL REMAINING IN THE MICROCATHETER WAS INSERTED INTO THE ANEURYSM AS MUCH AS POSSIBLE, BUT THE PROXIMAL PART OF THE COIL COULD NO LONGER BE INSERTED, SO THE SAME STENT WAS DEPLOYED IN THE COIL ASSISTANT STENT (STRYKER ATLAS) THAT WAS PREVIOUSLY DEPLOYED IN THE PARENT ARTERY SO THAT THE COIL LOOP DOES NOT INJURE THE ARTERY AND PROCEDURE WAS FINISHED. THE FINAL ANGIO PHOTO AFTER THE SURGERY SHOWS THE PATIENT HAD NO SERIOUS INJURIES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343169 ↗
• MalfunctionFeb 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORT SENT TO FDA BY USER FACILITY: "DURING ANEURYSM COILING COIL DETACHED WITHOUT BEING RELEASED BY PROVIDER."

  Patient problems: Insufficient Information

  MAUDE report 11334038 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172390. One submission often covers many models, so check the product and lot details in each record.

• Z-1988-2025 · May 8, 2025 · Open, Classified
  Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI020
• Z-1680-2022 · Jul 26, 2022 · Open, Classified
  Optima Coil System Model OPTI0520CSF10. For endovascular embolization.