Optima Coil System OPTI0827CSF10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053026232), received between Dec 21, 2022 and Mar 26, 2026 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMar 26, 2026Stretched; Separation Problem

  IT WAS REPORTED THAT: "THE PHYSICIAN, WHILE TREATING AN A-COM ANEURYSM, PLANNED TO TREAT BY STANDARD COILING. TOOK ACCESS TO THE LOCATION WITH BALLAST 90 LONG SHEATH AND NAVIEN DISTAL ACCESS CATHETER , PHYSICIAN TOOK ACCESS TO ANEURYSM WITH SL 10 MICRO-CATHETER AND TRAXCESS MICRO WIRE , REMOVED THE WIRE AFTER ACCESSING INSIDE TO THE ANEURYSM AND SUCCESSFULLY PLACED THE MICRO CATHETER INSIDE THE ANEURYSM , TOOL OPTIMA 8MM 27 SOFT COMPLEX AS THE FIRST COIL . PRECHECKED THE COIL AND GAVE A GREEN SIGNAL , STARTED COOLING AND WHEN TRIED TO DETACH THE XCEL CONTROLLER GAVE A GREEN SIGNAL OF SUCCESSFUL DETACHMENT , BUT THE COIL WASN'T DETACHED AND EVEN AFTER AFTER MULTIPLE ATTEMPTS WITH DIFFERENT DETACHERS IT WASN'T DETACHING .PHYSICIAN DECIDED TO TOOK IT BACK . WHILE RETRIEVING THE COIL GOT STRETCHED AND DETACHED AND PHYSICIAN HAD TO CATCH IT BACK WITH A CATCHMINI STENT RETRIEVER. RESUMED COOLING WITH DIFFERENT SIZES AND CASE FINISHED SUCCESSFULLY AND PATIENT EXTUBATED AND DOING FINE WITH MEDICATIONS ON". INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701082 ↗
• InjuryDec 21, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "PROCEDURE: STENT ASSISTED COILING OF AN ACOM ANEURYSM. PRODUCTS ACCESSED: NEURONMAX 6F 90CM, NAVIEN 072", GAMA17_DS, ATLAS, 1X STRYKER'S 360 COIL 9X30. OPTIMA COMPLEX-10 SOFT 8X27 WAS THE 2ND COIL. THE COIL WAS TAKEN OUT OF THE DISPENSER, BACK FLUSHED AND LOADED INTO GAMA17. UPON LOADING, DR FELT FRICTION INSIDE THE COIL. THE COIL WAS RETRIEVED BACK INTO ITS PROTECTIVE WHITE SLEEVE AND INSPECTED. NO STRETCHING, PRE-DETACHMENT, OR KINK WAS SEEN. COIL WAS LOADED BACK INTO GAMA, LOADING WAS SMOOTH. THE FIRST 4TH LOOPS OF THE COIL WAS DEPLOYED IN ONE GO (DR DID NOT HAVE CONTROL OF THE COIL), DR WAS NOT HAPPY WITH THE COIL'S SHAPE, HE TRIED TO REPOSITION THE COIL AND FELT THAT THE COIL WAS PRE-DETACHED. THE DETACHED COIL WAS LATER RETRIEVED OUT OF THE ANEURYSM USING CATCHVIEWMAXI50. DUE TO LOSS OF CONTROL OF THE COIL DEPLOYMENT, THE TIP OF THE ANEURYSM WAS PERFORATED. PERFORATION WAS THROMBOSED FEW HOURS AFTER THE CASE AND PATIENT IS OK." (B)(6) 2022, ADDITIONAL INFORMATION PROVIDED BY ISSUER - "- IT IS MENTIONED THAT "DR DID NOT HAVE CONTROL OF THE COIL". IS THIS JUST INDICATING THAT THE COIL PREMATURELY DETACHED? YES THE COIL HAD PREMATURELY DETACHED INSIDE THE

  Patient problems: Headache; Muscle Weakness/Atrophy

  MAUDE report 16024551 ↗

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.