Optima Coil System OPTI0615CSFMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818053025204), received between Apr 10, 2020 and Mar 21, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

4 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. 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.

• MalfunctionMar 21, 2025Stretched; Stretched

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN DISEASE NAME: 6 MM ANEURYSM IN IC-PC PROCEDURE: PLANNED PROCEDURE MICRO CATHETER: UNKNOWN ASSIST STENT: NEUROFORM ATLAS STENT SYSTEM 4.5MM 21MM/STRYKER Y CONNECTOR: UNKNOWN USED COILS: 1ST COIL/OPTIMAX, 2ND COIL/NAIROBI (MEDTRONIC), 3RD COIL: I-ED[?](KANEKA MEDIX). <DESCRIPTION> THE OPTIMAX 6×15 COIL WAS USED AS THE FIRST COIL. THE PHYSICIAN PLACED A STENT-ASSISTED ATLAS 4.5MM X 21MM AND PERFORMED FRAMING IN A SEMI-JAIL CONFIGURATION. THE POSTERIOR COMMUNICATING ARTERY WAS BRANCHING FROM THE TARGET ANEURYSM, AND SEVERAL ATTEMPTS WERE MADE TO RE-COIL TO ENSURE THE COIL DID NOT OBSTRUCT THE P-COM. HOWEVER, WHEN RETRACTING, THE COIL DID NOT FOLLOW, LEADING THE PHYSICIAN TO DETERMINE THAT THE COIL HAD STRETCHED. A SNARE DEVICE WAS INSERTED INTO THE MICROCATHETER, AND THE STRETCHED PORTION WAS CAPTURED AND REMOVED ALONG WITH THE MICROCATHETER. THE ENTIRE OPTIMAX 6×15 COIL WAS RETRIEVED OUTSIDE THE BODY, WITH NO REMNANTS IN THE ANEURYSM. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING COMPETITIVE COILS. THE PROCEDURE DID NOT INVOLVE TORTUOUS ANATOMY. IT IS UNKNOWN WHETHER THE PHYSICIAN PERFORMED THE PRE-USE CHECK OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668629 ↗
• MalfunctionJan 24, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN DISEASE NAME: VERTEBRAL ARTERY DISSECTION, EMBOLIZATION SIZE: UNKNOWN PROCEDURE: EMERGENCY PROCEDURE MICRO CATHETER: UNKNOWN ASSIST STENT: UNKNOWN Y CONNECTOR: UNKNOWN USED COILS: AS PER BELOW. <DESCRIPTION> IN A CASE OF VERTEBRAL ARTERY DISSECTING ANEURYSM, COIL EMBOLIZATION WAS PERFORMED WITH A DOUBLE CATHETER TECHNIQUE ON BOTH THE ANEURYSM AND THE DISSECTION AREA. FIRST, AN OPTIMAX 6-15 COIL WAS DEPLOYED INSIDE THE ANEURYSM, FOLLOWED BY A COMPETITIVE COIL (MANUFACTURER UNKNOWN) DEPLOYED IN THE DISSECTION AREA. THE COMPETITIVE COIL IN THE DISSECTION AREA WAS DETACHED FIRST. SUBSEQUENTLY, WHEN ATTEMPTING TO DETACH THE OPTIMAX 6-15 COIL, THE XCEL DETACHMENT CONTROLLER (LOT# F240900329) INDICATED ALTERNATING RED AND GREEN LIGHTS, AND THE IMPLANT COIL COULD NOT BE DETACHED. MULTIPLE DETACHMENT ATTEMPTS WERE MADE, BUT THE XCEL STILL INDICATED RED AND GREEN LIGHTS. (IT WILL BE REPORTED AS YA2024-1053.) THE XCEL WAS REPLACED WITH A NEW ONE (LOT#F240500242), WHICH ALSO SHOWED RED AND GREEN LIGHTS. EVEN AFTER CHANGING THE INSERTION ANGLE AND WIPING OFF THE GOLD CONNECTOR, THE SITUATION DID NOT CHANGE, AND EVEN THE THIRD XCEL (LOT#

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230079 ↗
• 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 ATLAS 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

  Patient problems: Paralysis

  MAUDE report 20077484 ↗
• MalfunctionApr 10, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "THE 6X15 WAS THE 3RD COIL PLACED IN THE ANEURYSM. AFTER MULTIPLE TIMES REPOSITIONING THE COIL THE CATHETER CAME OUT OF THE ANEURYSM AND THROUGH THE ATLAS STENT. THE PHYSICIAN ATTEMPTED TO ADVANCE THE CATHETER BACK OVER THE COIL TO RECROSS THE STENT BUT WAS UNABLE TO. AFTER ATTEMPTING MULTIPLE TIMES, THE PHYSICIAN DECIDED TO REMOVE THE COIL. AFTER REMOVING ABOUT 10CM THE COIL DETACHED IN THE MICRO CATHETER LEAVING 5CM STILL IN THE ANEURYSM. THE MICROCATHETER WAS REMOVED AND THE COIL WAS REMOVED USING A SOLITAIRE 6X40 AND A VELOCITY. HE FINISHED THE CASE SAFELY."

  Patient problems: Aneurysm

  MAUDE report 9949493 ↗

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-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-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