Optima Coil System OPTI0407CSF10 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053026096), received between Jan 28, 2022 and Jun 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

3 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. 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 ↗

2. Jan 4, 2022Open, Classified

   Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.

   Z-0660-2022 · Root cause: Process control · FDA record ↗

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.

• MalfunctionJun 8, 2022Stretched; Stretched

  IT WAS REPORTED THAT: "THE PHYSICIAN TRIED TO EMBOLIZE THE OPTIMA COIL INTO TARGET LESION AS FIRST COIL AFTER DEPLOYING ATLAS STENT. DURING PLACING IMPLANT COIL, THE PHYSICIAN FOUND DIFFICULTY TO OPERATE ITS MOVEMENT VIA PUSHER WIRE. THEN THE PHYSICIAN DECIDED TO WITHDRAW THE COIL SYSTEM AND NOTICED THAT THE COIL GOT UNRAVELED AND FAIL OF VESSEL. THE COILS HAD BEEN RETRIEVED BY SNARE AND THE PROCEDURE WAS COMPLETED WITH COMPETITIVE COIL." 20MAY2022, ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "THE COIL DID NOT GET PREMATURELY DETACHED NOR SNAPPING APART. THE REASON WHY THE PHYSICIAN USED SNARE WAS IT WAS DIFFICULT TO RETRIEVE DISTAL PART OF COIL BY PULLING PUSHER WIRE SINE THERE WAS UNRAVELED PART BETWEEN THEM. THE MOST PART OF COIL WAS REMAINED ANEURYSM HOWEVER WERE PARTLY PULLED OUR BY ATTEMPT OF RETRIEVE. WHERE WAS THE IMPLANT RETRIEVED FROM WITH THE SNARE? WAS THE IMPLANT LOCATED IN THE MICROCATHETER OR OUTSIDE OF THE MICROCATHETER WHEN IT WAS RETRIEVED? IT WAS MAINLY FROM TARGET LESION(ANEURYSM) AND MAIN VESSEL. HOW WAS THE ANATOMY OF THE PATIENT, WAS IT TORTUOUS? WE HAVE NOT HEARD THERE WAS TORTUOUS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14639193 ↗
• MalfunctionJan 28, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT: "THEY SAY INSIDE DE EXTERNAL THE REFERENCE WAS DIFFERENT THAN THE ONE ON THE EXTERNAL BOX OUTSIDE CARD BOX LABEL OPTI0407CSF10 F210500135, INSIDE CONTAIN OPTI0204CSF10 DU LOT F210500134. PRODUCT WAS NOT USE AND POUCH REMAIN UN OPENED (CLOSED) WE CAN BRING BACK ALL BEFORE USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389359 ↗

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-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.