Optima Coil System OPTI0611CSFMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053025198), received between Jul 8, 2021 and Jun 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING AN 8MM PCOMM RUPTURED ANEURYSM WITH MUTIPLE LOBES. WE STARTED OUT BY USING A 7 X 15MM OPTIMAX THROUGH AN SL-10. UPON NOT BEING ABLE TO GET THE COIL TO SIT PROPERLY, THE PHYSICIAN INTRODUCED AN ECHELON 10 MICRO AND THE 6MM X 11CM OPTIMAX TO TRY AND GET THE COILS TO PLAY OFF ONE ANOTHER. WITH BOTH CATHETERS AND COILS IN THE ANEURYSM, WE WERE ABLE TO GET THE 7 X 15MM OPTIMAX TO SIT AND DETATCHED THE COIL. FOLLOWING DETATCHMENT, WE MANIPULATED THE 6MM X 11CM COIL A BIT AND IT PREMATURELY DETATCHED, HALF THE COIL WAS IN THE ANEURYSM AND THE OTHER HALF WAS IN THE PARENT VESSEL. THERE WAS TOO MUCH COIL HANGING INTO THE PARENT VESSEL TO TRY AND LAY A STENT. WE ENDED UP HAVING TO SNARE THE COIL OUT OF THE BODY. WE DID SO SUCCESSFULLY. WHILE SNARING OUT THE 6MM COIL, IT ENDED UP PULLING THE 7MM DETATCHED COIL INTO THE TOP PART OF THE ANEURYSM AND INTO THE PARENT VESSEL. WE THEN HAD TO USE A STENTRIEVER TO PULL OUT OF THE 7MM COIL AS WELL. FOLLOWING ALL THOSE EVENTS, WE ENDED UP LAYING AN ATLAS STENT AND PROCEEDED TO COIL THE ANEURYSM SUCCESSFULLY." UPDATE 15MAY2025 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. DID THE PROCEDURE INVOL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196507 ↗
• MalfunctionJul 8, 2021Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN TRIED REPOSITIONING THE OPTIMAX SOFT 6X11 4 TIMES. DECIDED TO PULL COIL OUT AND TRY A OPTIMAX 5X7. ONE LOOP WAS LEFT IN THE ANEURYSM AND THE COIL DETACHED. HE DECIDED TO PUSH THE COIL IN BUT ONE OF THE LOOPS PROTRUDED IN THE A2. TRIED TO WIRE A2 BUT COULD NOT. LEFT PATIENT AS IS. WILL RETRY TOMORROW." FOLLOW UP (06-JUL-2021): "THE PHYSICIAN HAD TO ADVANCED THE COIL INTO THE ANEURYSM WITH THE PUSHER AFTER IT PREMATURELY DETACHED. HE COULD NOT PULL THE COIL OUT BECAUSE IT WAS THROUGH A STENT AND HE DID NOT WANT TO RISK THE STENT MOVING PROXIMATELY. UNFORTUNATELY ONE OF THE LOOPS OF THE COIL PROTRUDING INTO THE A1 SEGMENT. HE TRIED MULTIPLE WIRES TO GET AROUND THE LOOP TO PUT IN ANOTHER STENT BUT COULD NOT DO IT AND DID NOT WANT TO RISK MOVING THE STENT THAT HAD ALREADY BEEN PLACED IN A2. HE HAS DECIDED TO WAIT SIX WEEKS FROM THE PROCEDURE DATE, HOPING THE STENT AND POSSIBLY THE PROTRUDED LOOP MAY ENDOTHELIALIZE. AT THAT POINT IN TIME HE WILL MAKE A DECISION ON WHAT THE NEXT STEPS WILL BE." FOLLOW UP (24-AUG-2021): "I SPOKE WITH DR. GUPTA. THE FOLLOW-UP ON THIS PATIENT WAS FINE. THERE WERE NO ISSUES."

  Patient problems: Insufficient Information

  MAUDE report 12139957 ↗

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