Optima Coil System OPTI0930CSFMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818053025266), received between Dec 23, 2021 and Nov 7, 2024 — classified as 4 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.

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.

• MalfunctionNov 7, 2024Stretched; Stretched

  IT WAS REPORTED THAT: "PATIENT INFORMATION: SEX: UNKNOWN, DISEASE NAME: 10 MM ANEURYSM AT THE C2 PORTION OF THE IC, PROCEDURE: PLANNED PROCEDURE, MICRO CATHETER: GREACH/TOKAI MEDICAL PRODUCTS INC., PHENOM 17/MEDTRONIC, AND EXCELSIOR 1018/STRYKER, GUIDING CATHETER: UNKNOWN, ASSIST STENT: ATLAS 3X21/STRYKER Y CONNECTOR: UNKNOWN. USED COILS: KENEKA COILS (QTY. 6), TERUMO COILS (QTY. 5), JAPAN LIFELINE COILS (QTY. 4), OPTIMA COILS (QTY. 4), MEDTRONIC COILS (QTY. 2), AND STRYKER COIL (QTY. 1). DETAILED DESCRIPTION: FOR THE ANEURYSM AT THE C2 PORTION OF THE IC, THE PHYSICIAN PERFORMED COIL EMBOLIZATION USING A DOUBLE CATHETER TECHNIQUE. THE REPORTED OPTIMA COIL WAS USED AS THE SECOND COIL. INITIALLY, AN AXIUM PRIME 10×40 COIL WAS DEPLOYED AS A FRAMING COIL WITH A PHENOM 17 MICROCATHETER, WITHOUT DETACHMENT. SUBSEQUENTLY, THE REPORTED OPTIMA COIL WAS DEPLOYED FROM A GREACH MICROCATHETER. WHILE REPOSITIONING THE OPTIMA IMPLANT COIL WITHIN THE ANEURYSM TO ACHIEVE THE DESIRED SHAPE, THE PHYSICIAN FOUND THAT THE COIL HAD STRETCHED. THEREFORE, THE PHYSICIAN DETACHED THE FIRST AXIUM PRIME 10×40 COIL, INSERTED A GUIDEWIRE, AND REPLACED THE PHENOM 17 MICROCATHETER WITH AN EXCELSIOR 1018. USING A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632154 ↗
• MalfunctionSep 27, 2024Migration; Premature Separation; Migration; 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 YA2024-0634.) THE PROCEDURE DID NOT INVOLVE TORTUOUS ANATOMY. IT IS UNKNOWN WHETHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323015 ↗
• MalfunctionApr 26, 2024Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  IT WAS REPORTED THAT: "HERE ARE THE PICTURES FROM THE UNIVERSITY OF LOUISVILLE HOSPITAL CASE THAT I CALLED YOU ABOUT. CCF ON A GUNSHOT VICTIM. I WILL GET THE FORM FILLED OUT AN EMAIL TONIGHT OR TOMORROW MORNING. I WANTED TO GET THIS COIL INTO THE MAIL BEFORE I LEFT ON VACATION IN THE MORNING." UPDATE 04APR2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "INCIDENT HAPPENED IN AN EMERGENT TRAUMA CASE. 19YO MALE SHOT IN THE FACE CAUSING A DIRECT CCF. THE PHYSICIAN DECIDED TO TRY AND SAVE THE ICA INSTEAD OF SACRIFICING. HE JAILED A MICROVENTION DUO 156CM MICRO CATHETER WITHIN THE CAVERNOUS SINUS BEHIND TWO PIPELINE DEVICES. AFTER LAYING TWO TELESCOPING PIPELINES HE BEGAN COILING THROUGH JAILED MICRO. STARTED WITH TWO LARGE AXIUM COILS THEN SWITCHED TO A OPTIMAX 9X30. HE FELT A LITTLE PRESSURE WHEN PUSHING THE OUR COIL OUT. HE GOT A 1/3 OF THE COIL OUT WHILE FEELING SOME FRICTION AND PRESSURE. HE TRIED TO WITHDRAW THE COIL AND FELT MORE FRICTION AND PRESSURE AND IT WOULDN'T REMOVE. HE TRIED TO ADVANCE THE COIL AGAIN WITH LOADS OF FRICTION AND PRESSURE. WHEN HE TRIED TO REMOVE THE COIL IT SNAPPED AND BROKE. HE SPENT AN ADDITIONAL 2 HOURS OF A 6 HOUR CASE USING A SNARE OVER THE CAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192480 ↗
• MalfunctionDec 23, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "PREMATURE DETACHMENT OF THE COIL DURING COIL POSITIONING INTO THE EMBOLIZATION SITE. MICROCATHETER USED: EXCELSIOR 17XT STRAIGHT. COIL RETRIEVED WITH A LASSO SYSTEM." FOLLOW UP (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED FROM ISSUER:" WAS THERE TORTUROUS ANATOMY INVOLVED? NO." FOLLOW UP (B)(6) 2021: ADDITIONAL INFORMATION RECEIVED FROM ISSUER: "WHERE DID THE IMPLANT PREMATURELY DETACH? DID IT OCCUR INSIDE OF THE MICROCATHETER? ABSOLUTELY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078462 ↗

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