Optima Coil System OPTI0513CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053025990), received between Aug 18, 2023 and Jan 14, 2025 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT: "DURING THE PROCEDURE, THE THIRD COIL COULD NOT BE ADVANCED INTO THE ANEURYSM. PUSHING THE COIL BACK AND FORTH, PRE-DETACH OCCURRED. THE UNRAVELED COIL WAS HELD IN PLACE AGAINST THE VESSEL WALL WITH A STENT. THE PRE-DETACH CAUSED A MAJOR COMPLAINT." UPDATE 16DEC2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: 9. HOW WOULD THE TORTUOSITY BE DESCRIBED IN THIS PROCEDURE? TAEWOONG'S ANSWER: THERE WERE NO ABNORMALITIES. 10. CAN YOU CONFIRM IF THE SUPPLEMENTAL ACCESSORIES WILL BE RETURNED? (MICROCATHETER, ETC) IF SO, IT WOULD BE APPRECIATED. TAEWOONG'S ANSWER: THEY WILL NOT BE RETURNED. 11. WAS THE USAGE OF THE STENT A RESULT OF THIS INCIDENT? TAEWOONG'S ANSWER: THE STENT WAS USED TO FIX THE STRETCHED IMPLANT COIL TO THE VESSEL WALL AFTER PRE-DETACH OCCURRED." UPDATE 30DEC2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. CAN YOU CONFIRM IF THE IMPLANT COIL WAS ABLE TO ADVANCE OUT OF THE INTRODUCER SHEATH? TAEWOONG'S ANSWER: IT WAS ABLE TO ADVANCE OUT OF THE INTRODUCER SHEATH WELL. 2. DID THE PROCEDURE INVOLVE TORTUOUS ANATOMY? TAEWOONG'S ANSWER: YES, THE ANATOMY WAS VERY TORTUOUS. 3. WILL THE MICROCATHETER BE AVAILABLE FOR RETURN? TAEWOONG'S ANSWER:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150103 ↗
• MalfunctionAug 18, 2023Poor Visibility; Poor Visibility

  IT WAS REPORTED THAT: "I DID NOT NOTICE THIS DURING THE CASE BUT DOCTOR THOUGHT THE TIGER STRIPES WERE OFF. HE SAID HE BURIED TIGER STRIPES INTO THE RHV AND HE THOUGHT COIL WAS ALREADY OUT OF THE CATHETER AT THAT POINT. AFTER THE CASE WAS OVER HE ADMITTED THAT MAYBE HE WAS WRONG AND THAT HE PUSHED IT TO FAR BUT I TOLD HIM I WOULD HAVE IT CHECKED OUT AND LET HIM KNOW." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573079 ↗

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.