Optima Coil System OPTI0212BLK (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840303712435), received between Feb 5, 2026 and Aug 27, 2026 — classified as 1 injury, 1 malfunction.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• InjuryAug 27, 2026Migration; Premature Separation

  It was reported that:" During a coil embolization of bi-lateral MMA for Csdh, the physician attempted to deploy his last coil an OptiBLOCK 2x12 coil through a Sl-10 Microcatheter. As he advanced the coil he attempted to reposition and lost 1 to 1 and it was observed that the coil was no longer attached to delivery wire. He attempted to use delivery wire and a Synchro wire to push the remainder of the coil out of SL-10. This was noted to be difficult and he had to leave a long coil tail into the Maxillary.Coil was prepped per DFU. No patient injury occurred. " Incident Report Form submitted for this complaint indicates that no patient injury was sustained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50476904 ↗
• MalfunctionFeb 5, 2026Stretched; Premature Separation

  IT WAS REPORTED THAT: "ADVANCE COIL AS NORMAL INTO PLATS MC. AFTER SOME MANEUVERING IN AND OUT WITH COIL, THE COIL BROKE (WAS WHAT I WAS TOLD). LOOKS TO BE SOME PART OF THE PUSHER BROKE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. UPDATE 13JAN2026- ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: " WHERE WAS THE IMPLANT COIL LOCATED WHEN THE PREMATURE DETACHMENT OCCURRED (INSIDE THE MICROCATHETER, AT THE TREATMENT LOCATION, ETC.)? -RMMA, THE COIL DETACHED OUTSIDE THE CATHETER IN THE R-MMA. THE MD USED THE CATHETER AND EASILY MANEUVERED THE COIL INTO PLACE WHERE HE INTENDED ONCE THE IMPLANT COIL WAS DETACHED, WHAT STEPS DID THE PHYSICIAN TAKE TO PROCEED WITH THE CASE? DO YOU HAVE ANY IMAGES FROM THE CASE AVAILABLE? -NO IMAGES CAN YOU PROVIDE THE TRACKING INFORMATION FOR THE RETURNING UNIT? -PRODUCT WAS SENT BACK WITH THE CORRESPONDING RG#, ARRIVES 1-13 I BELIEVE TO PRODUCT COMPLAINTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269341 ↗