Optima Coil System OPTI0208CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053025815), received between Jul 12, 2023 and May 14, 2026 — classified as 3 malfunctions.

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

3 FDA recall records name this device's identifier, 3 still open.

1 other recall 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 ↗

3. Sep 7, 2022Open, Classified

   Product pouch label does not match up with carton label

   Z-0103-2023 · Root cause: Error in labeling · 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.

• MalfunctionMay 14, 2026Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING AN AVM ON A 3.5-YEAR-OLD PATIENT. HE TREATED THE FEEDING VESSEL WITH 3 OPTIBLOCK MINI COILS AND HAD A GREAT RESULT. HE PERFORMS RESEARCH AND TAKES A COIL AND MOVES IT AROUND IN THE AREA OF THE AVM SO HE CAN TAKE THE CELLS AND DO TESTING FOR RESEARCH. UNFORTUNATELY, WHILE HE WAS ALLOWING THE COIL TO MOVE INSIDE THE AVM, THE COIL DETACHED. PHYSICIAN UNDERSTANDS IT MAY BE DUE TO THE STRESS THAT WAS PUT ON THE COIL. HE WAS ABLE TO SNARE THE COIL AND DID NOT CAUSE ANY NEGATIVE HARM TO PATIENT AND WAS ABLE TO RESUME CASE SUCCESSFULLY. USED A HEADWAY DUO 167 MICRO." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174428 ↗
• MalfunctionMar 15, 2024Stretched; Stretched

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: 75 YEARS OLD FEMALE DISEASE NAME: 7MM OF AN IN IC-PC PROCEDURE: PLANNED PROCEDURE MICRO CATHETER: GREACH/TOKAI MEDICAL ASSIST STENT: UNKNWON Y CONNECTOR: UNKNOWN USED COILS: AVENIR/JLL <DESCRIPTION> THE PHYSICIAN EXPERIENCED 2 UNRAVEL EVENTS. [?]OPTIMAX: 7MM-20CM(REPORTED AS YA2023-1095) [?]OPTIMA 2MM-8CM(YA2023-1097) YA2023-1097: AFTER YA2023-1095, 5 OPTIMAX COILS AND 5 AVENIR COILS WERE PLACED WITH TRANS CELL TECHNIQUE. THE PHYSICIAN CHOSEN 2-8MM OPTIMA. DURING INSERTION, 4 CM PROXIMAL SIDE OF THE IMPLANT COIL COULD NOT BE PLACED TARGET LESION. MULTIPLE ATTEMPTS OF REPOSITIONING RESULT IN UNRAVEL. THE PHYSICIAN TRIED TO RETRIEVE UNRAVELED COIL BUT THE MASS OF THE COIL BECAME TRAPPED IN THE VESSEL AROUND C4 AND DIFFICULT TO RETRIEVE. THE PHYSICIAN DID EVERYTHING TO RECOVER THE MASS OF COILS, WHICH FELL FROM THE C4 POSITION TO THE PETRAS AREA, BUT IT WAS UNABLE TO RETRIEVE. THE PHYSICIAN HAD TO PLACE LVIS STENT(ONLY 5.5MM WAS AVAILABLE DESPITE THE VESSEL WAS 4.5MM) TO PRESS THE MASS OF COIL INTO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITH PTA USING SHORYU (BALLOON)." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912518 ↗
• MalfunctionJul 12, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT: "THIS IS TO INFORM YOU THAT WE FOUND A PRODUCT WHOSE INFORMATION ON THE POUCH LABEL DIFFERS FROM THE LABEL ON THE BOX DURING INCOMING INSPECTION. AS OF NOW THE AMOUNT OF PRODUCT WITH DISCREPANCY IS 1. BOX: OPTI0208CSS10 F220601068 POUCH: OPTI0308CSS10 F220601089".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313322 ↗

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-1680-2022 · Jul 26, 2022 · Open, Classified
  Optima Coil System Model OPTI0520CSF10. For endovascular embolization.