Optima Coil System OPTI0152CSSMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818053024955), received between Jul 2, 2021 and May 29, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Migration; Premature Separation

  IT WAS REPORTED THAT: "DURING EMBOLIZATION OF AN ACOM ANEURYSM, THE PHYSICIAN POSITIONED AN SL-10 MICROCATHETER WITHIN THE ANEURYSM AND REQUESTED AN OPTIMAX SS 1.5 X 2 COIL. AS THE COIL WAS ADVANCED THROUGH THE MICROCATHETER, IT WAS VISUALIZED UNDER FLUOROSCOPY WITHIN THE CATHETER. HOWEVER, UPON ADVANCING THE FINAL QUARTER OF THE COIL INTO THE ANEURYSM, LOSS OF ONE-TO-ONE RESPONSE OCCURRED, AND THE COIL COULD NEITHER BE ADVANCED NOR RETRACTED. USING THE DELIVERY WIRE, THE PHYSICIAN WAS ABLE TO ADVANCE THE REMAINING PORTION OF THE COIL INTO THE ANEURYSM. FOLLOW-UP IMAGING DEMONSTRATED THE 1.5 X 2 OPTIMAX COIL POSITIONED AT THE ANEURYSM NECK AND WITHIN THE ACOM. ON SUBSEQUENT IMAGING, THE COIL HAD MIGRATED INTO THE A2 SEGMENT. THE DELIVERY WIRE WAS REMOVED, AND THE SL-10 MICROCATHETER WAS WITHDRAWN. THE PHYSICIAN URGENTLY REQUESTED A TREVO RETRIEVAL SYSTEM, INCLUDING A TRAK 21 MICROCATHETER AND TREVO STENT RETRIEVER. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE MIGRATED COIL, DURING WHICH THE COIL CONTINUED TO MOVE DISTALLY. AFTER THREE PASSES, SUCCESSFUL RETRIEVAL WAS ACHIEVED USING A LARGER TREVO STENT RETRIEVER. THE COIL WAS PREPARED ACCORDING TO THE DFU. THE DELIVERY WIRE AND COIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25332925 ↗
• MalfunctionNov 7, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS DOING A RUPTURED ACOM ANEURYSM COILING. HE WAS USING A 90CM BALLAST, A 6F SOFIA, WITH A PLATO MICROCATHETER. HE ALSO HAD AN ECLIPSE BALLON PREPARED AND UP AROUND THE ICA TERMINUS. THE FIRST COIL IN THE ANEURYSM WAS A 1.5X2 OPTIMAX. THE ANEURYSM WAS VERY SMALL, MEASURING ABOUT 1.8X2.2. THE PLATO CATHETER WAS VERY DISTAL IN THE ANEURYSM, ALMOST AT THE DOME. THE COIL SET UP NICELY, WE TESTED THE DETACHMENT AND GOT A SOLID GREEN. WENT TO DEPLOY, AND GOT THE SOUND AND APPEARANCE OF A GOOD DETACH. WHEN PULLING BACK, THERE WAS CLEAR SPACE BETWEEN THE EDGE OF THE MICROCATHETER AND THE DETACHMENT ZONE. HOWEVER, WHEN PULLING BACK HARDER THE COIL MASS BEGAN TO MOVE. THE PHYSICIAN WAS ABLE TO PUSH BACK FORWARD, BUT PUSHED THE PUSHER WIRE THROUGH THE DOME OF THE ANEURYSM. THANKFULLY, THERE WAS NO EXTRAVIZATION DUE TO THERE BEING COIL PRESENCE AND MICROCATHETER TAKING UP SPACE. AT THIS POINT, WE WENT BACK TO TRY ANOTHER DETACH AND WE WERE ABLE TO PULL THE PUSHER WIRE BACK. THERE WAS NO PATIENT INJURY AND WE IMPLANTED ONE MORE COIL AFTER THIS." UPDATE 10OCT2025 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "IT WAS NOT VERY TORTUOUS AT ALL. YES, THE SE

  Patient problems: Rupture

  MAUDE report 23500830 ↗
• MalfunctionAug 18, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT: "PHYSICIAN WAS COILING A RUPTURED PCOM ANEURYSM THROUGH A PHENOM 017 45 DEGREE MICROCATHETER. AFTER DELIVERING FINAL COIL (OPTIMAX 1.5MM X 2CM), THE PHYSICIAN DETACHED THE COIL USING THE NORMAL DETACHMENT PROCESS. PHYSICIAN WAS SLIGHTLY OVERALIGNED (A VERY SMALL AMOUNT OF DAYLIGHT BETWEEN THE 3CM MARKER ON THE COIL AND THE 3CM MARKER ON THE PUSHER). PHYSICIAN GOT A SOLID GREEN, PRESSED BUTTON ONCE, AND HAD NORMAL DETACHMENT RESPONSE. SHE THEN PULLED THE PUSHER BACK TO CONFIRM DETACHMENT ~0.5CM AND SAW A CLEAR GAP BETWEEN THE PUSHER AND THE COIL. PHYSICIAN THEN REMOVED THE PUSHER, AND DURING REMOVAL OF THE PUSHER THE COIL PULLED BACK INTO THE MICROCATHETER APPROX 1.5CM. PHYSICIAN HAD ALREADY REMOVED THE PUSHER FROM THE MICROCATHETER AND DECIDED TO PUSH THE REMAINDER OF THE COIL INTO THE ANEURYSM USING A MICROWIRE. PHYSICIAN WAS ABLE TO SUCCESSFULLY IMPLANT THE REMAINING COIL INTO THE ANEURYSM WITH NO CLINICAL COMPLICATION OR INJURY TO THE PATIENT. THE CASE FINISHED WITH THE COIL COMPLETELY IMPLANTED INTO THE ANEURYSM. STAFF DISPOSED OF THE PUSHER WIRE BEFORE IT COULD BE GATHERED AND RETURNED." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828415 ↗
• InjuryJul 2, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "COIL PREDETACHED IN RHV AND CATHETER. DUE TO CHALLENGES WITH THE CASE THE MICROCATHETER COULD NOT BE REMOVED. TRIED TO PUSH COIL WITH ANOTHER COIL. HAD TO USE A WIRE TO ADVANCE THE COIL. WHILE ADVANCING COIL INTO AN, COIL PROTRUDED THROUGH DOME OF AN. AFTER ADVANCING WHOLE COIL IN AN, ADDED MORE COILS TO ACHIEVE STASIS." (B)(6) 2021 FOLLOW UP (1): WHAT IS THE STATUS OF THE PATIENT? PT WAS SIMILAR STATE AFTER THE PROCEDURE. PT IS STABLE. THIS WAS AN INCREDIBLY SICK PATIENT PRIOR TO THE PROCEDURE. CAN YOU ELABORATE WHEN YOU SAY THE COIL PROTRUDED THROUGH THE DOME OF THE ANEURYSM? DOES THIS MEAN THAT THE ANEURYSM RUPTURED? SECOND QUESTION, THE COIL ENDED UP IN THE SUBARACHNOID SPACE HOWEVER THERE WAS NO EXTRAVASATION OF CONTRAST. THIS WAS A SECOND COILING OF A PT THAT PREVIOUSLY HAD A SAH. THE COIL WENT THROUGH HE DOME BUT THERE WAS NO EXTRAVASATION OF CONTRAST.

  Patient problems: Ruptured Aneurysm

  MAUDE report 12111900 ↗

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