Optima Coil System OPTI0517CSFMXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818053025181), received between Aug 11, 2021 and Nov 25, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K200030); 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Stretched; Optical Problem; Migration; Stretched; Optical Problem; Migration

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN DISEASE NAME: ANEURYSM (LESION SITE: A-COM, LESION SIZE: 6 MM) PROCEDURE: PLANNED PROCEDURE, MICRO CATHETER: UNKNOWN, ASSIST STENT: UNKNOWN, Y CONNECTOR: UNKNOWN, USED COILS: UNKNOWN. <DESCRIPTION> IN A CASE OF AN A-COM ANEURYSM, THE PHYSICIAN ATTEMPTED COILING USING THE DOUBLE CATHETER TECHNIQUE. AFTER NEARLY COMPLETING FRAMING WITH A TARGET XL SOFT 6×20 COIL, THE PHYSICIAN PROCEEDED TO DEPLOY AN OPTIMAX 5×17 COIL. DURING THE PROCEDURE, THE OPTIMAX 5×17 COIL PROTRUDED FROM THE NECK OF THE ANEURYSM. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL, THE OPTIMAX 5×17 BECAME STRETCHED AND COULD NEITHER BE ADVANCED NOR WITHDRAWN. SUBSEQUENTLY, THE OPTIMAX 5X17 COIL WAS SAFELY RETRIEVED USING A SNARE DEVICE. THE PROCEDURE WAS THEN CONTINUED USING AN AXIUM COIL FOR FRAMING AND COMPLETED WITHOUT FURTHER ISSUES. THERE WAS VESSEL TORTUOSITY NEAR THE C1 SEGMENT, AND MICROCATHETER CONTROL WAS DIFFICULT; HOWEVER, NO ISSUES WERE OBSERVED WHEN USING OTHER COMPANIES' COILS. PRE-USE CHECK OF THE OPTIMAX 5×17 REVEALED NO ABNORMALITIES." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646327 ↗
• MalfunctionSep 6, 2024Stretched; Stretched

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN DISEASE NAME: 4.3 MM ANEURYSM IN A2-A3 PROCEDURE: PLANNED PROCEDURE MICRO CATHETER: PNOVUS/JAPAN LIFELINE ASSIST STENT: NEUROFORM ATLAS/STRYKER Y CONNECTOR: UNKNOWN USED COILS: AS PER BELOW. <DESCRIPTION> THE PHYSICIAN PERFORMED STENT-ASSISTED COIL EMBOLIZATION OF WIDE-NECK ANEURYSM AT THE A2-A3 BRANCH POINT AND CHOSE THE OPTIMAX 5X17 AS A FRAMING COIL. AFTER DEPLOYMENT OF THE NEUROFORM ATLAS, THE PHYSICIAN ATTEMPTED TO FRAME THE ANEURYSM WITH THE OPTIMAX 5X17 USING JAILED TECHNIQUE. DURING THE PROCESS OF REPOSITIONING THE OPTIMAX 5X17 SEVERAL TIMES TO GET THE DESIRED SHAPE, IT BECAME UNRAVELING. THEREFORE, THE PHYSICIAN CUT THE HUB OF THE MICROCATHETER AND RETRIEVED THE OPTIMAX 5X17 WITH SNARE. AFTER THAT, THE PROCEDURE WAS COMPLETED WITH COMPETITIVE COIL. THE PHYSICIAN COMMENTED THAT THE UNRAVELING OCCURRED AT THE COIL WIRE DISTAL TO THE DELIVERY PUSHER, NOT AT THE IMPLANT COIL. THE DISTAL ACCESS CATHETER WAS ADVANCED UP TO THE IC TOP. FROM THE IC TOP TO BEYOND THE ACA, THERE WERE NO TORTUOUS ANATOMY. IT IS UNKNOWN WHETHER THE PHYSICIAN PERFORMED THE PRE-USE CHECK." UPDATE 13AUG2024 - ADDITIONAL INFORMATION RECEIVED FROM T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158863 ↗
• InjuryJun 28, 2024Stretched; Separation Failure; Stretched; Separation Failure

  IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX: UNKNOWN DISEASE NAME: 5 MM ANEURYSM IN A-COM PROCEDURE: PLANNED PROCEDURE MICRO CATHETER: SL-10/STRYKER, PHENOM 17/MEDTRONIC, PHENOM 21/MEDTRONIC* * THE PHENOM 21 WAS USED TO DELIVER A GOOSE NECK SNARE SK400 TO THE LESION. ASSIST STENT: ATLAS 4X30/STRYKER Y CONNECTOR: UNKNOWN USED COILS: PRIME/MEDTRONIC (QTY. 4), AVENIR/JAPAN LIFELINE (QTY.2) OTHERS: GOOSE NECK SNARE SK400 <DESCRIPTION> FOR THE A-COM LESION, THE PHYSICIAN PERFORMED COIL EMBOLIZATION USING A DOUBLE CATHETER TECHNIQUE. FIRST, AN OPTIMAX 5X17 WAS PLACED WITH THE SL-10. NEXT, THE PHYSICIAN IMPLANTED A COMPETITIVE COIL WITH THE PHENOM 17. AT THIS POINT, THE PHYSICIAN DID NOT DETACH THE IMPLANT COIL OF THE OPTIMAX, AND AFTER SIX COMPETITIVE COILS WERE IMPLANTED USING THE PHENOM 17, THE PHYSICIAN ATTEMPTED TO DETACH THE OPTIMAX. ALTHOUGH THE OPTIMAX HAD NO PROBLEM IN PRE-USE CONTINUITY CHECK, WHEN ATTEMPTING TO DETACH, THE XCEL (LOT# F230900777) INDICATED AN ALTERNATING RED-GREEN LIGHT. WHEN THE GOLD CONNECTOR WAS WIPED AND RECONNECTED, THE XCEL INDICATED A GREEN LIGHT AND THE RELEASE BUTTON WAS PRESSED BUT COULD NOT BE DETACHED. (IT WILL BE REPORTED AS (B)(4)). THE XCEL W

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19638921 ↗
• MalfunctionAug 11, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "PHYSICIAN WAS DEPLOYING A 5X17 MAX AND IT DETACHED AFTER GETTING A FEW LOOPS INTO THE ANEURYSM. HE HAD TO RETRIEVE IT WITH A 6MM TREVO AFTER FAILING WITH A 4MM TREVO. HE SAID HE WAS FEELING FRICTION WHEN HE WAS ADVANCING THE COIL AND THAT IT CAME OFF WHEN HE WAS REPOSITIONING. AFTER RETRIEVING IT, HE PLACED TWO XL COILS. HE SAID THERE WAS A LOT OF SPASM AND IT WAS A VERY CHALLENGING CASE."

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 12309487 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200030. One submission often covers many models, so check the product and lot details in each record.

• Z-1988-2025 · May 8, 2025 · Open, Classified
  Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI020
• 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.
• Z-0660-2022 · Jan 4, 2022 · Open, Classified
  The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil del