Optima Coil System OPTI0620CSFMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818053025211), received between Jun 10, 2021 and Sep 27, 2024 — classified as 6 malfunctions.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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.

• MalfunctionSep 27, 2024Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN DISEASE NAME: 9MM DIRECT CCF, DAVF PROCEDURE: PLANNED PROCEDURE MICRO CATHETER: UNKNOWN ASSIST STENT: UNKNOWN Y CONNECTOR: UNKNOWN USED COILS: 1ST COIL/OPTIMAX 9×30, 2ND COIL/OPTIMAX 6×20. <DESCRIPTION> THE PHYSICIAN ATTEMPTED TO DEPLOY THE OPTIMAX 9×30 AS THE 1ST COIL. DURING DEPLOYMENT, THE PHYSICIAN CONSIDERED THAT THE COIL SIZE WAS LARGE, SO HE DECIDED TO RETRIEVE IT. WHILE RETRIEVING THE OPTIMAX 9×30, THE IMPLANT COIL DID NOT FOLLOW, AND WAS UNINTENTIONALLY DEPLOYED WITHIN THE PARENT VESSEL. FORTUNATELY, THE UNINTENDED DEPLOYMENT OF THE IMPLANT COIL RESULTED IN THE OCCLUSION OF THE TARGET BLOOD FLOW AS DESIRED. (IT WILL BE REPORTED AS (B)(4). AFTER THAT, THE PHYSICIAN CHOSE THE OPTIMAX 6X20 AS THE 2ND COIL. THE PHYSICIAN ATTEMPTED TO DEPLOY THE COIL WITHIN THE LESION SITE, BUT HE FINALLY DECIDED TO RETRIEVE IT. WHILE RETRIEVING THE OPTIMAX 6X20, THE COIL WAS UNRAVELING. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO RETRIEVE THE COIL AND RETRIEVED IT ALONG WITH THE MICROCATHETER, AND THE PROCEDURE WAS COMPLETED. (IT WILL BE REPORTED AS (B)(4). THE PROCEDURE DID NOT INVOLVE TORTUOUS ANATOMY. IT IS UNKNOWN WHETHER THE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322964 ↗
• MalfunctionJun 17, 2024Stretched; Stretched

  IT WAS REPORTED THAT: "PATIENT INFORMATION. SEX: UNKNOWN; DISEASE NAME: 7 MM ANEURYSM IN IC-PC; PROCEDURE: PLANNED PROCEDURE; MICRO CATHETER: SL-10/STRYKER; ASSIST STENT: ATLAS/STRYKER, ELVIS/TERUMO; Y CONNECTOR: UNKNOWN; USED COILS: AS PER BELOW. DESCRIPTION. FOR AN ANEURYSM OF APPROXIMATELY 7 MM, THE PHYSICIAN PLACED A TARGET XL 6-20 INTO THE ANEURYSM AS A FRAMING COIL, BUT IT DID NOT FIT WELL, SO TWO OPTIMAX 6-20S WERE PLACED, BUT BOTH UNRAVELED. WHEN THE PHYSICIAN USED THE FIRST OPTIMAX 6-20 (LOT# F231000599), THE IMPLANT COIL WAS PLACED IN THE ANEURYSM WITHOUT REALIZING THAT THE MICROCATHETER HAD RUPTURED THE BLEB. BECAUSE THE IMPLANT COIL WAS DISPLACED FROM THE ANEURYSM, THE YOUNG SURGEON PULLED ON THE COIL, RESULTING IN A SLIGHT UNRAVELING OF THE IMPLANT COIL. (IT WILL BE REPORTED AS (B)(4).) THE SECOND OPTIMAX 6-20 (LOT# F231100245) WAS UNRAVELED IN THE PROCESS OF THE PHYSICIAN REPOSITIONING THE COIL ABOUT 10 TIMES. (IT WILL BE REPORTED AS (B)(4).) BOTH THE FIRST AND SECOND OPTIMAX 6-20 COULD BE DETACHED. THE PROCEDURE WAS COMPLETED IN A POSITION TO SUPPRESS THE UNRAVELING PARTS OF THE TWO OPTIMAX 6-20'S BY ARRANGING THE STENTS (ATLAS 4.5X30, ATLAS 4X21, LVIS 5.5X30, AND LV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549050 ↗
• MalfunctionJun 17, 2024Stretched; Stretched

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN. DISEASE NAME: 7 MM ANEURYSM IN IC-PC . PROCEDURE: PLANNED PROCEDURE. MICRO CATHETER: SL-10/STRYKER. ASSIST STENT: ATLAS/STRYKER. Y CONNECTOR: UNKNOWN. USED COILS: AS PER BELOW. <DESCRIPTION> FOR AN ANEURYSM OF APPROXIMATELY 7 MM, THE PHYSICIAN PLACED A TARGET XL 6-20 INTO THE ANEURYSM AS A FRAMING COIL, BUT IT DID NOT FIT WELL, SO TWO OPTIMAX 6-20S WERE PLACED, BUT BOTH UNRAVELED. WHEN THE PHYSICIAN USED THE FIRST OPTIMAX 6-20 (LOT# F231000599), THE IMPLANT COIL WAS PLACED IN THE ANEURYSM WITHOUT REALIZING THAT THE MICROCATHETER HAD RUPTURED THE BLEB. BECAUSE THE IMPLANT COIL WAS DISPLACED FROM THE ANEURYSM, THE YOUNG SURGEON PULLED ON THE COIL, RESULTING IN A SLIGHT UNRAVELING OF THE IMPLANT COIL. (IT WILL BE REPORTED AS (B)(4).) THE SECOND OPTIMAX 6-20 (LOT# F231100245) WAS UNRAVELED IN THE PROCESS OF THE PHYSICIAN REPOSITIONING THE COIL ABOUT 10 TIMES. (IT WILL BE REPORTED AS (B)(4).) BOTH THE FIRST AND SECOND OPTIMAX 6-20 COULD BE DETACHED. THE PROCEDURE WAS COMPLETED IN A POSITION TO SUPPRESS THE UNRAVELING PARTS OF THE TWO OPTIMAX 6-20'S BY ARRANGING THE STENTS (ATLAS 4.5X30, ATLAS 4X21, LVIS 5.5X30, AND LVIS 4.5X28).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549035 ↗
• MalfunctionMar 28, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "DURING THE COILING OF A RUPTURED OPTHALMIC ANEURYSM, THE PHYSICIAN HAD A PREMATURE DETACHMENT OF AN OPTIMAX 6X20 COIL TODAY. THE PHYSICIAN INITIALLY FRAMED THE ANEURYSM SUCCESSFULLY WITH AN OPTIMAX 8X30. ON THE DEPLOYMENT OF HIS SECOND COIL AN OPTIMAX 6X20, THE PHYSICIAN NOTED HE FELT A POP ABOUT HALF WAY THROUGH THE DEPLOYMENT AND LOST ONE TO ONE. HE HAD TO SNARE THE COIL AND REMOVE. NO PATIENT INJURY OCCURED. COIL AND PUSHER ARE AVAILABLE FOR RETURN." 02MAR2023, ADDITIONAL INFORMATION PROVIDED BY ISSUER: " WAS THE ANATOMY TORTUOUS? MILD. WAS FRICTION EXPERIENCED DURING THE ADVANCEMENT OF THE 6X20 COIL, OR EVEN BY THE 8X30 COIL? THE PHYSICIAN SAID THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE 8X30. HE REPORTED THAT HE HAD LITTLE RESISTANCE WITH 6X20 BUT NOTED THAT HIS MICROCATHETER KICKED BACK MULTIPLE TIMES AND HE WAS MANIPULATING CATHETER AND COIL TO REPOSITION. CAN YOU PLEASE CONFIRM MY UNDERSTANDING WHEN REPORTED "HALFWAY THROUGH THE DEPLOYMENT": THE POP WAS EXPERIENCED DURING IMPLANT TRANSFER FROM MICROCATHETER TIP TO TREATMENT SITE. THE IMPLANT COIL WAS STENT RETRIEVED WITH A PORTION OF THE IMPLANT DEPLOYED FROM THE MICROCATHETER TIP? AFTER HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627704 ↗
• MalfunctionOct 21, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "PHYSICIAN HAD A PREMATURE DETACHMENT OF A 6X20 OPTIMAX COMPLEX SOFT. USING AN ECHELON 10 THE PHYSICIAN DEPLOYED 11 DEPLOYED COILS INTO A FACIAL AVM. ON THE 12TH COIL HE TRIED REPOSITIONING THE 6X20 SEVERAL TIMES DUE TO IT NOT BEING THE RIGHT SIZE. UPON REMOVAL, THE COIL PREMATURLY DETACHED. THE PHYSICIAN REMOVED THE CATHETER AND RETRIEVED COIL WITH SNARE, SAFELY REMOVING IT FROM THE VESSEL. NO PATIENT INJURY OCCURED. I HAVE PRODUCT AVAILABLE FOR RETURN. LOOKS LIKE THE SNARE IS ALSO INCLUDED IN RETURN PACKAGE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651413 ↗
• MalfunctionJun 10, 2021Migration; Migration

  IT WAS REPORTED THAT: "AN UNEXPECTED TAIL OCCURRED DURING THE PROCEDURE CAUSING THE PHYSICIAN TO HAVE TO PLACE AN ATLAS STENT TO TACK IT DOWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975976 ↗

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