Optima Coil System OPTI0720CSFMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818053025235), received between Jan 12, 2024 and May 22, 2026 — classified as 1 injury, 3 malfunctions.

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

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

3 other recalls cover devices cleared under the same FDA submission (K200030); 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. 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 · FDA record ↗

2. 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 ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 27, 2024Migration; Migration

  IT WAS REPORTED THAT: "PATIENT INFORMATION: SEX: UNKNOWN. DISEASE NAME: 7 MM ANEURYSM IN MCA. PROCEDURE: PLANNED PROCEDURE. MICRO CATHETER: UNKNOWN. ASSIST STENT: NEUROFORM ALAS 3.0 MM X 21 MM/STRYKER. Y CONNECTOR: UNKNOWN. USED COILS: OPTIMAX 7X20 (1ST COIL) , OPTIMAX 6X15 (2ND COIL), I-ED COMPLEX INFINI 3-5X15/KANEKA MEDIX (3RD COIL). DESCRIPTION: AFTER PLACEMENT OF THE MICROCATHETER TIP INSIDE THE ANEURYSM, THE NEUROFORM ATLAS STENT WAS DEPLOYED FROM THE INFERIOR TRUNK TO THE MCA, AND THEN COIL EMBOLIZATION WAS PERFORMED WITH THE JAILING TECHNIQUE. THE PHYSICIAN PLACED OPTIMAX 7X20 AND OPTIMAX 6X15 INTO THE ANEURYSM AS THE FIRST AND SECOND COILS, RESPECTIVELY, AND THE IMPLANT COILS WERE SUCCESSFULLY DETACHED. AFTER THAT, THE PHYSICIAN INSERTED THE IED COMPLEX INFINITI 3-5X15 INTO THE ANEURYSM, ATTEMPTED TO DEPLOY IT, AND FOUND THAT THE STRAIGHTENED COIL HAD THE BEHAVIOR OF MIGRATING OUT OF THE ANEURYSM. THEREFORE, THE PHYSICIAN RETRIEVED THE IED COIL. THE COIL THAT MIGRATED OUTSIDE OF THE ANEURYSM REMAINED IN THE SAME PLACE, AND IT WAS UNCLEAR WHETHER IT WAS THE OPTIMAX 7X20 OR THE OPTIMAX 6X15. THE PATIENT'S MONITOR VALUE WAS BAD JUST AFTER STENT PLACEMENT, SO THE PROCEDURE WAS

  Patient problems: Paralysis

  MAUDE report 20077359 ↗
• MalfunctionMar 15, 2024Stretched; Migration; Premature Separation; Stretched; Migration; Premature Separation

  IT WAS REPORTED THAT: "PATIENT INFORMATION: SEX: 75 YEARS OLD FEMALE. DISEASE NAME: 7MM OF AN IN IC-PC. PROCEDURE: PLANNED PROCEDURE. MICRO CATHETER: GREACH/TOKAI MEDICAL. ASSIST STENT: UNKNOWN. Y CONNECTOR: UNKNOWN. USED COILS: AVENIR/JLL. DESCRIPTION: THE PHYSICIAN EXPERIENCED 2 UNRAVEL EVENTS. OPTIMAX: 7MM-20CM (REPORTED AS YA2023-1095) TIMA 2MM-8CM(YA2023-1097) YA2023-1095: IT WAS DOUBLE CATHETER PROCEDURE. USING GREACH/TOKAI MEDICAL MICRO CATHETERS, OPTIMAX(7-20) AND (6-15) WERE DEPLOYED ALTERNATELY BUT IT WAS DIFFICULT TO WIND OFF THE TWO COILS AT THE SAME TIME AND ATTEMPTS WERE MADE TO RE-IMPLANT THEM OVER 20 TIMES. AFTER THAT, THE 6-15 WAS DETACHED FIRST AND ANOTHER COIL WITH 5-10 WAS INSERTED. DURING ATTEMPT TO DEPLOYMENT, THE COIL 7-20 GOT UNRAVELED. THUS, THE PHYSICIAN TRIED TO RETRIEVE THE COILS. THE COIL WITH 5-10 WAS RETRIEVED SUCCESSFULLY BUT 7-20 WAS DETACHED WHILE ATTEMPTING TO RETRIEVE IT WITH A MICROCATHETER AND SNARE. AT THIS TIME, PART OF THE COIL WILL BE IN THE MOTHER VESSEL BY ABOUT 3 CM. TO TREAT IT, SL10 WAS GUIDED, A STENT (ATLAS 4-21/STRIKER) WAS DEPLOYED, AND THE REMAINING COIL WAS CRIMPED TO THE MASS WALL AND THE PROCEDURE CONTINUED." INCIDENT REPORT FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912491 ↗
• MalfunctionJan 12, 2024Stretched; Stretched

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN INITIAL OF PATIENT NAME: (B)(6) YEARS: 61 DISEASE NAME: 10MM OF ANEURYSM IN BA-TOP PROCEDURE: PLANNED TAE MICRO CATHETER: UNKNOWN ASSIST STENT: ATLAS/STRYKER Y CONNECTOR: UNKNOWN USED COILS: UNKNOWN <DESCRIPTION> IT WAS PROCEDURE FOR MULTI ANEURYSMS. ONE WAS 10MM OF BA-TOP AND THE OTHER WAS 4MM OF ANEURYSM. THE PHYSICIAN PLACED ATLAS STENT IN Y SHAPE AND STARTED PLACING COILS VIA TRANCE CELL TECHNIQUE FOR 4MM OF ANEURYSM. AFTER PLACING 4 COILS IN TOTAL (TETRA/3.5[?]6, 3.0-4.5, 3.0-4.5, 2.0-4.5(IT WAS RETRIEVED SINCE IT COULD NOT BE INSERTED IN TARGET LESION), OPTIMA2.5-4), THE PHYSICIAN STARTED EMBOLIZATION OF 10MM ANEURYSM IN BA-TOP[?]H.6.1/[?]W/8.4[?]D-8.0[?]. IT WAS STARTED WITH OPTIMAX10-40 AND AT THE POINT OF COMPLETED PLACING OF 9-30, THE VER WAS 32.4%. THEN THE PHYSICIAN TRIED TO INSERT OPTIMAX7-20 AND FOUND RESISTANCE AFTER INSERTED 3/4 OF IMPLANT COIL INTO ANEURYSM. THE PHYSICIAN TRIED TO RETRIEVE THE IMPLANT COIL. ACCORDING TO THE PHYSICIAN HE FOUND UNRAVEL AT THAT TIME. THE MULTIPLE ATTEMPTS FOR RETRIEVING WITH SNARE AND TREVO RETRIEVER COULD NOT CHANGE SITUATION. THEY HAD TO PLACE ADDITIONAL STENT (ATLAS) TO FIX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504419 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200030. One submission often covers many models, so check the product and lot details in each record.

• Z-0103-2023 · Sep 7, 2022 · Open, Classified
  Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
• Z-1680-2022 · Jul 26, 2022 · Open, Classified
  Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
• Z-0660-2022 · Jan 4, 2022 · Open, Classified
  The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil del