Optima Coil System OPTI0203CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053025785), received between Mar 25, 2021 and Aug 15, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2024Stretched; Stretched

  IT WAS REPORTED THAT: "DURING THE PROCEDURE THE COIL WAS STRETCHED AND WAS TAKEN OUT OF THE BODY WITH SOLITAIRE STENT. TOTAL OF 3 OPTIMA COIL STRETCH DEFECTS OCCURRED IN THE PROCEDURE, SO 1 COIL AND 2 DELIVERY SYSTEM WILL BE RETURNED. 2 OF THE COILS WERE LOST DURING THE RETRIEVAL WITH THE SOLITAIRE STENT. IT WAS DIFFICULT TO VISUALLY DISTINGUISH THE RETURNED COIL IMPLANT FROM THE 3 STRETCH FAILURE, SO THE LABEL WILL BE ATTACHED." UPDATE 18JUL2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: " 1. WHEN EXACTLY DID THE STRETCHING OCCUR FOR EACH OF THE THREE COILS? - WHEN POSITIONING THE COIL BY INSERTING AND REMOVING. 2. WAS THE STENT DEVICE USED ONLY TO RETRACT ONE COIL? OR WAS A STENT DEVICE USED FOR EACH OF THE THREE STRETCHED COILS? - ONE STENT WAS USED TO REMOVE 3 COILS. 3. DID THE PATIENT SUSTAIN ANY INJURY? - NO 4. WHEN IT IS MENTIONED THAT "2 OF THE COILS WERE LOST DURING THE RETRIEVAL WITH THE SOLITAIRE STENT", WHAT WAS THE OUTCOME OF THIS PROCESS? WHAT HAPPENED TO THESE TWO COILS? - IT WAS DISCARDED WITH THE SOLITAIRE STENT." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19994840 ↗
• MalfunctionAug 15, 2024Stretched; Stretched

  IT WAS REPORTED THAT: "DURING THE PROCEDURE THE COIL WAS STRETCHED AND WAS TAKEN OUT OF THE BODY WITH SOLITAIRE STENT. TOTAL OF 3 OPTIMA COIL STRETCH DEFECTS OCCURRED IN THE PROCEDURE, SO 1 COIL AND 2 DELIVERY SYSTEM WILL BE RETURNED. 2 OF THE COILS WERE LOST DURING THE RETRIEVAL WITH THE SOLITAIRE STENT. IT WAS DIFFICULT TO VISUALLY DISTINGUISH THE RETURNED COIL IMPLANT FROM THE 3 STRETCH FAILURE, SO THE LABEL WILL BE ATTACHED." UPDATE 18JUL2024: ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "WHEN EXACTLY DID THE STRETCHING OCCUR FOR EACH OF THE THREE COILS? WHEN POSITIONING THE COIL BY INSERTING AND REMOVING. WAS THE STENT DEVICE USED ONLY TO RETRACT ONE COIL? OR WAS A STENT DEVICE USED FOR EACH OF THE THREE STRETCHED COILS? ONE STENT WAS USED TO REMOVE 3 COILS. DID THE PATIENT SUSTAIN ANY INJURY? NO WHEN IT IS MENTIONED THAT "2 OF THE COILS WERE LOST DURING THE RETRIEVAL WITH THE SOLITAIRE STENT", WHAT WAS THE OUTCOME OF THIS PROCESS? WHAT HAPPENED TO THESE TWO COILS? IT WAS DISCARDED WITH THE SOLITAIRE STENT." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19994452 ↗
• MalfunctionMar 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS BALLOON ASSIST COILING A RUPTURED MCA BIRFURCATION ANEURYSM. THE PHYSICIAN HAD PREVIOUSLY USED A 2.5X6 AXIUM, THEN OPTIMA 2X6 CSS, OPTIMA 2X4 CSS. THE COIL MASS WASN'T SITTING WELL DUE TO WIDE NECK. THE PHYSICIAN USED THE BALLOON TO PUSH THE COILS BACK INTO THE ANUERYSM. THE PHYSICIAN ADDED AN ADDITIONAL 2X3 OPTIMA CSS AND IT PACKED AND HELD THE COILS IN PLACE. THE PHYSICIAN WAS USING AN ADDITIONAL 2X3 OPTIMA CSS. THE PHYSICIAN DIDN'T LIKE HOW THE COIL WAS SITTING AND DECIDED TO PULL OUT THE COIL. THE PHYSICIAN FELT SOME FRICTION WHEN REMOVING AND CONTINUED TO PULL ON PUSHER TO THE REMOVE THE COIL AND THE COIL BROKE OFF THE PUSHER AT THE DETACHMENT ZONE LEAVING THE COIL HALF IN THE MICRO CATHETER. THE PHYSICIAN USED A SYRINGE FILLED WITH SALINE TO PUSH THE COIL OUT OF MICROCATHETER. THE PHYSICIAN HAD TO USE AN ATLAS STENT TO SECURE THE COILS DOWN. THE PHYSICIAN BELIEVES HE HAD TRAPPED THE COIL ON THE SIDE WALL BETWEEN THE CATHETER AND BALLOON. THE PHYSICAN DOESN'T BELIEVE THE COIL WAS TANGLED. PUSHER AVAILABLE FOR RETURN, NOT COIL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11571181 ↗

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-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.