Optima Coil System OPTIPAX3014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840303713715), received between Mar 6, 2026 and Mar 30, 2026 — classified as 2 malfunctions.

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.

• MalfunctionMar 30, 2026Failure to Advance; Premature Separation

  IT WAS REPORTED THAT: "MMA EMBOLIZATION. PHYSICIAN HAD A 6FR BENCHMARK, PLATO 17 MICROCATHETER, AND A 0.014" WIRE. FRONTAL BRANCH OF RIGHT MMA SELECTED WITH DISTAL ACCESS OF PLATO 17. PHYSICIAN BEGAN TO DEPLOY PAX, FELT SOME RESISTANCE WHILE PACKING AND THEN UPON ATTEMPTING TO MANIPULATE COIL HE FELT THE RESISTANCE GONE AND THE COIL WAS NO LONGER ATTACHED. HE PUSHED THE REST OF THE COIL OUT OF THE MICROCATHETER WIRE A WIRE THROUGH THE PLATO 17 AND IT WAS IN MMA AND THE IMAX." UPDATE 18MAR2026 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1.DID THE PROCEDURE INVOLVE TORTUOUS ANATOMY? NOT UNUSUALLY TORTUOUS. 2. WILL THE MICROCATHETER BE AVAILABLE FOR RETURN? NO 3. WHERE DID THE IMPLANT PREMATURELY DETACH? (INSIDE THE AN, INSIDE THE MC?, ETC) ABOUT 10CM OF THE COIL WAS IN THE ANTERIOR MMA BRANCH. THE REMAINING 20CM WAS WITHIN THE PLATO 17 MICROCATHETER AT TIME OF PREMATURE DETACHMENT 4. WERE ANY ATTEMPTS MADE TO DETACH THE IMPLANT COIL USING THE DETACHMENT CONTROLLER? NO 5. CAN YOU CONFIRM IF THE DEVICE WAS IMPLANTED? YES. IT WAS PUSHED OUT WITH A WIRE AND WAS PARTIALLY IN MMA AND IMAX ARTERIES." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716771 ↗
• MalfunctionMar 6, 2026Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING AN MMA WITHOUT PARTICLES, A COIL ONLY TECHNIQUE. HE WAS COILING THROUGH A PHENOM17 MICROCATHETER. INITIALLY THE COIL TRAVELLED DISTALLY AS EXPECTED, BUT WAS NOT BREAKING PROXIMALLY WHATSOEVER AND THE COIL WAS SO LONG THAT IT WAS KICKING THE CATHETER BACK ALL THE WAY INTO THE IMAX. EVENTUALLY WHILE MANEUVERING THE COIL TO TRY TO GET IT TO BREAK, THE COIL PREMATURELY DETACHED. AFTER MULTIPLE ATTEMPTS TO PUSH IT OUT OF THE MICROCATHETER WITH A WIRE, THE COIL ENDED UP STAYING IN THE IMAX." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539276 ↗