Optima Coil System OPTI0413CSF10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053026119), received between May 21, 2022 and Mar 19, 2026 — classified as 3 malfunctions.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Stretched

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN DISEASE NAME: A-COM PROCEDURE: PLANNED PROCEDURE MICRO CATHETER: SL-10, HEADWAY ASSIST STENT: ATLAS 4X20 GUIDE WIRE: UNKNOWN ASSIST BALLOON: UNKNOWN Y CONNECTOR: UNKNOWN USED COILS: OPTIMA, PRIME F, TARGET SOFT, TARGET ULTRA, <DESCRIPTION> THE 9TH COIL WAS USED IN AN ACOM ANEURYSM (ACOM AN) WITH OPTIMA. AFTER A DETACHMENT PHASE WITHOUT ANY ERROR INDICATOR, WHEN ATTEMPTING TO RETRIEVE THE DELIVERY PUSHER, THE COIL MOVED BACK AND REMAINED AT APPROXIMATELY 6 CM FROM THE DISTAL END OF THE MICROCATHETER. THE REMAINING COIL WAS ATTEMPTED TO BE RETRIEVED USING AN EXCELSIOR 1018 AND A 4 MM SNARE. ALTHOUGH THE COIL WAS SUCCESSFULLY SNARED AND REPEATEDLY PULLED INTO THE DAC, IT UNRAVELED AND COULD NOT BE COMPLETELY RETRIEVED FROM WITHIN THE ANEURYSM. THE FILAMENTS EXTENDED FROM THE ANEURYSM, THROUGH THE INTRACRANIAL, ALL THE WAY TO THE PUNCTURE SITE (FEMORAL ARTERY). SINCE THE FILAMENTS COULD BE EXTERNALIZED OUTSIDE THE BODY, THE PROCEDURE WAS CONCLUDED BY SUTURING THESE FILAMENTS AT THE FEMORAL. ACCORDING TO THE PHYSICIAN, WHO WAS VISITING FROM OSAKA ACUTE AND GENERAL MEDICAL CENTER FOR THIS PROCEDURE, THERE IS A HIGH LIKELIHOOD THAT

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639646 ↗
• MalfunctionOct 4, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN PLANNED TO DO ANEURYSM CASE. THE PLAN WAS TO USE OPTIMA COILS. AFTER GETTING ACCESS OF THE GUIDING CATHETER THEN TOOK THE SL10 & SYNCHRO GUIDE WIRE POSITION INTO TO THE ANEURYSM AND REMOVED THE WIRE. THE PHYSICIAN TOOK OPTIMA COMPLEX SOFT 4X13 FOR FIRST COIL. THE PHYSICIAN DEPLOYING THE COIL OFF OF THE COIL DEPLOYING AFTER THAT PLAN TO PUT STENT SO THE PHYSICIAN DEPLOYED THE STENT THEN FURTHER DEPLOYING THE COIL BUT UNABLE PUSH & PULL BACK THE COIL AND COIL WAS DETACHED THE PARENT ARTERY. THE PHYSICIAN REQUESTED THE COMPLIANT FOR THE DAMAGED LOT NUMBER OF THE COIL.THE PHYSICIAN TOOK ANOTHER FEW MORE COILS FINISHED THE CASE." UPDATE 17SEP2023 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "DID THE IMPLANT COIL PREMATURELY DETACH WITHIN THE PARENT ARTERY? YES. DID THE PHYSICIAN INTERVENE WITH THE USE OF A STENT DUE TO THE PREMATURELY DETACHED COIL? NO. CAN YOU CONFIRM THE PATIENT'S STATUS TO DATE? WAS ANY INJURY/ HARM SUSTAINED? NO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868553 ↗
• MalfunctionMay 21, 2022Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT: "OPTIMA COIL 4-13 WAS USED TO TREAT ICA WIDENECK ANEURYSM. WHILE DEPLOYING THE COIL TO FILL THE ANEURYSM, COIL WAS NOT PROPERLY FILLING IN THE ANEURYSM. AFTER GIVING MULTIPLE ATTEMPTS, COIL SEEMS TO GOT DAMAGED (STRETCHED). IT GOT PREMATURELY DETACHED INSIDE AND GOT COMPLETELY STRETCHED. COULD NOT RETRIEVE BACK THE STRETCHED PART. KINDLY CONSIDER THIS AS A PRODUCT FAILURE." UPDATE 29APR2022 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "·CAN YOU EXPLAIN WHERE THE COIL PREMATURELY DETACHED? WAS IT INSIDE THE MICROCATHETER OR OUTSIDE? · PREMATURELY DETACHED INSIDE MICROCATHETER, COIL WAS HALF DEPLOYED AND HALF INSIDE MICROCATHETER. ·WHAT HAPPENED WITH THE STRETCHED COIL THAT WAS UNABLE TO BE RETRIEVED? · COIL GOT STRETCHED COMPLETELY, IT BECAME LIKE THREAD. HALF COIL WAS INSIDE ANEURYSM AND REST STRETCHED THREAD HAD TO CUT FROM GROIN. ·TO CONFIRM, WAS ANY HARM ENDURED BY THE PATIENT? NO HARM WAS ENDURED BY THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466347 ↗

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.