Optima Coil System OPTI0103CSS10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053025723), received between Aug 18, 2023 and Jun 26, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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.

• MalfunctionJun 26, 2024Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT: "PATIENT INFORMATION: SEX: UNKNOWN, DISEASE NAME: 4 MM ANEURYSM WITH BLEB IN A-COM, PROCEDURE: EMERGENCY PROCEDURE, MICRO CATHETER: SL-10/STRYKER, PHENOM 17/MEDTRONIC, ASSIST STENT: UNKNOWN, Y CONNECTOR: UNKNOWN, USED COILS: AS PER BELOW. DESCRIPTION: THE PHYSICIAN ATTEMPTED TO FRAMING THE BLEB USING A TARGET TETRA (STRYKER) AS THE FIRST COIL. THE TARGET TETRA COIL WAS DAMAGED IN THE PROCESS OF REPOSITIONING AND PULLING BACK INTO THE SL-10 MICROCATHETER. THEREFORE, THE ENTIRE MICROCATHETER, INCLUDING THE COIL, WAS RETRIEVED WITH A SNARE AND REPLACED WITH A NEW MICROCATHETER, PHENOM17. AFTER THAT, THE OPTIMA 3X4 WAS PLACED AS A FRAMING COIL, AND THE TARGET NANO (STRYKER) WAS PLACED. THEN, THE PHYSICIAN USED THE REPORTED OPTIMA1X3 (LOT# 211000213) AND ONCE IN THE PROCESS OF PULLING IT BACK INTO THE MICROCATHETER FOR REPOSITIONING, AND THE PHYSICIAN FELT THE COIL SHREDDED AND FOUND THE COIL DETACHED EARLY INSIDE THE MICROCATHETER. DURING USE, THE TIP OF THE MICROCATHETER WAS NEAR THE CENTRAL AREA OF THE ANEURYSM, AND THERE WAS NO APPEARANCE OF A LOADING FORCE ON THE TIP OF THE MICROCATHETER. THE COIL WAS RETRIEVED BY PULLING IT INTO THE MICROCATHETER WITH THE ESP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615571 ↗
• MalfunctionAug 18, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT: "A SECOND OPTIMA COMPLEX SUPERSOFT 1X3 WAS OPENED AND DEPLOYED WITH EASE THROUGH THE SAME HEADWAY DUO 167CM MICROCATHETER. THE COIL WAS DETACHED AND PUSHER WIRE WAS REMOVED. DR. (B)(6) NOTED THAT AS HE PULLED BACK MIRCOCATHETER THAT THE COIL WAS "STUCK" AND MOVING WITH MICRO. HE INTRODUCED A GUIDEWIRE INTO MICROCATHER AND ADVANCED OUT THE TIP OF CATHETER MANIPULATING WIRE BACK AND FORTH TO ATTEMPT TO DISLODGE COIL. THE COIL CONTINUED TO ADHERE TO CATHETER. DR. (B)(6) REMOVED MICROCATHETER SYSTEM AND THE COIL CAME BACK WITH CATHETER. THE PHYSICIAN AND TECH OBSERVED THE COIL TO BE "STUCK" TO OUTSIDE OF MICRO CATHETER ON BACK TABLE. A NEW MICROCATHETER SYSTEM ALONG WITH PERIPHERAL PUSHABLE COILS WERE USED TO SUCCESSFULLY COMPLETE CASE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577610 ↗

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.