Optima Coil System OPTI2525CSSMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053025013), received between Aug 20, 2020 and Sep 16, 2020 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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

4 other recalls cover devices cleared under the same FDA submission (K200030); 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. 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.

• MalfunctionSep 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED: "AFTER FRAMING WITH THE 2.5X2.5 OPTIMAX THE PHYSICIAN DETACHED THE COIL AND OPENED A 1X1 OPTIMAX BUT WHEN HE WENT TO PLACE THE COIL HE NOTICED HIS MICROCATHETER HAD COME BACK. HE PULLED THE COIL OUT USED THE HYBRID 1214 TO ACCESS THE ANEURYSM BUT WHEN HE INSERTED THE SL-10 OVER THE WIRE INTO THE ANEURYSM IT DISLODGED THE 2.5Z2.5 OPTIMAX. THE PHYSICIAN DROPPED AN ATLAS STENT THROUGH THE COIL AND ACROSS THE NECK OF THE ANEURYSM AND THEN CROSSED THE STENT AND PLACED 5 OPTIMA COILS TO FINISH THE PROCEDURE. I HAVE INCLUDED IMAGES OF THE INITIAL FRAME, STENTED 2.5X2.5 AND THE FINAL RESULT."

  Patient problems: Aneurysm

  MAUDE report 10543953 ↗
• DeathAug 20, 2020Positioning Failure; Migration; Positioning Failure; Migration

  IT WAS REPORTED THROUGH AN AUTOMATED REPORTING SYSTEM FROM ACTIVE CLINICAL STUDY: "A SERIOUS ADVERSE EVENT WAS ADDED: SITE ID: #105. PATIENT ID: (B)(6). YEAR OF BIRTH: 1954. ADVERSE EVENT FORM NUMBER: #3. EVENT DESCRIPTION: PATIENT DECEASED. DATE OF EVENT ONSET: (B)(6) 2020. SERIOUSNESS: LED TO A DEATH. RELATIONSHIP TO OPTIMA COILS SYSTEM: RELATIONSHIP TO PROCEDURE: RELATIONSHIP TO A BALT DEVICE: IF YES, SPECIFY DEVICE: IF YES, SPECIFY RELATIONSHIP: OTHER RELATIONSHIP: IF YES, SPECIFY: ACTION: EVENT STATUS: DEATH. DATE OF EVENT RESOLUTION OR DEATH: (B)(6) 2020. CREATED BY: (B)(6). DATE OF CREATION: 7/3/20 1:23 PM. FOLLOW UP PROVIDED (07/17/2020): 'THE DEATH OCCURRED SEVERAL MONTHS AFTER THE PROCEDURE WITH OPTIMA COILS IN ANOTHER HOSPITAL NOT INVOLVED IN THE INSTANT STUDY THAT IS WHY WE HAVE DIFFICULTIES TO COLLECT THE RELATIONSHIP TO THE STUDY DEVICE. THE HOSPITAL WHERE THE DEATH OCCURRED INFORM US THAT THE REPORT WILL BE AVAILABLE AFTER 10TH OF AUGUST ( DUE TO HOLIDAYS )AND NOT BEFORE. THE INSTANT STUDY SITE STAFF WHERE THE PATIENT WAS ENROLLED ( FRENCH SITE IN BORDEAUX) DOESN'T THINK THAT THE EVENT IS LINKED TO THE OPTIMA BUT TO BE SURE WE NEED TO WAIT FOR THE DEATH REPORT (FROM

  Patient problems: Aneurysm; Death; Pulmonary Emphysema

  MAUDE report 10431348 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200030. 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.
• Z-0660-2022 · Jan 4, 2022 · Open, Classified
  The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil del