Optima Coil System OPTI0220BLKRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840303711858), received between Jul 18, 2025 and May 14, 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.

• MalfunctionMay 14, 2026Premature Separation

  IT WAS REPORTED THAT: "DURING A COIL EMBOLIZATION OF MMA FOR CSDH, THE PHYSICIAN ATTEMPTED TO DEPLOY OPTIBLOCK 2X20 COIL THROUGH A SL-10 MICROCATHETER. THE COIL PUSHED BACK THE SL-10 AS IT WAS ADVANCED OUT OF DISTAL END. THE PHYSICIAN RESHEATHED COIL AND REPOSITIONED MICRO MORE DISTAL. HE THEN RELOADED THE OPTIBLOCK 2X20 COIL AND AFTER DEPLOYING THE FIRST TWO LOOPS OF COIL HE LOST 1 TO 1 AND IT WAS OBSERVED THAT THE COIL WAS NO LONGER ATTACHED TO DELIVERY WIRE. HE USED A SYNCHRO WIRE TO PUSH THE REMAINDER OF THE COIL OUT OF SL-10. THIS WAS NOTED TO BE DIFFICULT BUT THE ENTIRE COIL WAS ULTIMATELY PUSHED INTO VESSEL. COIL WAS PREPPED PER DFU. NO PATIENT INJURY OCCURRED. THE DELIVERY WIRE IS AVAILABLE FOR RETURN." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174268 ↗
• MalfunctionJul 18, 2025Stretched; Migration; Premature Separation; Stretched; Migration; Premature Separation

  IT WAS REPORTED THAT: "WHEN RESHEATHING THE 2X20 COIL IN THE HEADWAY DUO 156CM MICROCATHETER IN THE MMA, THE COIL STRETCHED AND THEN BROKE OFF THE DELIVERY WIRE. THE COIL WAS NOT ABLE TO BE RECAPTURED AND WAS LEFT IN THE ECA WHERE IT BROKE OFF. FORTUNATELY, NO PATIENT HARM. THE SAME MICROCATHETER WAS USED TO DELIVER COILS FOR THE REMAINDER OF THE CASE." UPDATE 23JUN2025 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: " IS IT KNOWN APPROXIMATELY WHERE THE ACTUAL "BREAK" ALONG THE COIL TOOK PLACE (DID IT OCCUR AT THE DETACHMENT ZONE, DID THE IMPLANT COIL WIND BREAK, ETC.)? THE ACTUAL COIL IMPLANT STRETCHED MIDWAY THROUGH AND THEN BROKE AT THE DETACHMENT ZONE. WHERE IT IS MENTIONED "WHEN RESHEATHING THE 2X20 COIL IN THE HEADWAY DUO 156CM MICROCATHETER IN THE MMA", DOES THIS MEAN THE IMPLANT WAS DEPLOYED FROM THE MC AND THE PHYSICIAN WAS ATTEMPTING TO RETRACT BACK INTO THE MICROCATHETER? THE MICROCATHETER WAS KICKING BACK AS HE WAS TRYING TO DEPLOY THE COIL, SO THERE WAS SOME RESHEATHING OF THE COIL INSIDE THE MICROCATHETER TO REPOSITION. BASED ON THE ANATOMICAL LOCATION OF THE PROCEDURE, WHAT LEVEL OF VESSEL TORTUOSITY WOULD YOU CONSIDER WAS ENCOUNTERED BY THE COIL SYSTEM? THERE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546351 ↗