Optima Coil System OPTI0517CST10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053026294), received between Jul 2, 2026 and Jul 2, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Separation Problem

  IT WAS REPORTED THAT: "- DURING THE PROCESS OF PUSH "5 X 17 CST" INTO ANEURYSM, THE ANEURYSM WAS RUPTURED. - SO, USER ATTEMPTED TO FORM A FRAME WITH "5 X 17 CST" SEVERAL TIMES, THE COIL WAS DETACHED. - ACCORDING TO THE MENTION OF ASSISTANT, THE PROCEDURE WAS SIGNIFICANTLY DELAYED DUE TO REMOVE THE COIL. - THE USER CONSIDERED, BECAUSE THE USER TRIED FRAME PROCEDURE WITH SOME TENSION, THE PRE-DETACH CAME OUT. - THE USER DID NOT COMPLAIN SO MUCH AT THIS TIME, BUT WE HAVE SAME ISSUE ALREADY (3RD APRIL), WE ARE REQUIRED TO CONSIDER ABOUT PRE-DETACH ISSUE OF 5X17CST WHICH HAS SAME LOT NUMBER AND SIZE." UPDATE 15JUN2026 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. WOULD YOU BE ABLE TO CONFIRM IF OUR UNDERSTANDING IS CORRECT: A. THE PHYSICIAN WAS ATTEMPTING TO EMBOLIZE THE ANEURYSM AND DURING THE ATTEMPT TO PUSH THE OPTI0517CST10 TO THE TREATMENT LOCATION, THEY RUPTURED THE ANEURYSM? NO. 2. THE COMPLAINT DESCRIPTION STATES "THE PROCEDURE WAS SIGNIFICANTLY DELAYED DUE TO REMOVE THE COIL" HOW DID THE PHYSICIAN REMOVE THE COIL? A. WHERE DID THE IMPLANT PREMATURELY DETACH? (INSIDE THE ANEURYSM, OR MICROCATHETER, ETC)- M/C. 3. HOW WOULD THE TORTUOSITY OF THE ANATOMY BE DESCRIBED? N/A.

  Patient problems: Ruptured Aneurysm

  MAUDE report 25692940 ↗

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-1988-2025 · May 8, 2025 · Open, Classified
  Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI020
• 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.