Prestige Coil System PRES0520HPKPLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053027192), received between Oct 12, 2021 and Sep 30, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 8, 2025Class IIOpen, Classified

   Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

   Z-1989-2025 · Root cause: Vendor change control · Recall details · FDA record ↗

2. Jan 3, 2024Class IIOpen, 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-1042-2024 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2022Migration; Migration

  IT WAS REPORTED THAT: "AFTER THE COIL WAS PLACED AND SEATED IN THE VESSEL WHEN PLACE ANOTHER COIL ON TOP OF THE 5MM HEILCAL LISTED ABOVE IT FLOATED UP INTO THE HEPATIC. WHILE IT WAS BEING SNARED THE COIL BROKE APART AND CAME OUT INTO TWO PIECES." 31AUG2022, ADDITIONAL INFORMATION - "CAN YOU CONFIRM THERE WERE NO FURTHER COMPLICATIONS WITH THE PATIENT? NOT DURING THE CASE. CAN YOU PROVIDE MORE DETAILS ABOUT THE PROCEDURE? HOW MANY COILS WERE USED TO TREAT THE SITE? A TOTAL OF THREE COILS WERE USED BUT TWO HAD TO BE SNARED AND ONLY ONE STAYED IMPLANTED. HOW MANY COILS WERE PLANTED BEFORE THE REPORTED COIL? THE COILS THAT MIGRATED WAS THE SECOND COIL USED AND FLOATED WHILE THE THIRD COIL WAS BEING PLACED. WAS THE ENTRANCE OF THE ANEURYSM WIDE, CAUSING THE COIL TO MIGRATE OUT OF THE TREATMENT SITE? THIS WAS NOT AN ANEURYSM IT WAS A GDA VESSEL." 22SEP2022 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "THERE WE NO MORE COMPLICATIONS AFTER THE COILS WERE COMPLETELY SNARED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15511933 ↗
• MalfunctionOct 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: "DR. (B)(6) WAS TREATING A BLEED AT THE GDA ORIGIN. AFTER ADVANCING 4 PRESTIGE PLUS COILS SUCCESSFUL SHE WENT TO ADVANCE A PRES0520HPKPL COIL BUT IT WASN'T FORMING THE WAY SHE WANTED. SHE THEN THOUGHT SHE RESHEATHED THE COIL AND DID A CONTRAST RUN. ONCE SHE DID THE RUN SHE NOTICED THE COIL FLY OUT OF THE MICROCATHETER AND GO IN THE HEPATIC ARTERY, THUS THE PRESTIGE PLUS 5X20CM WAS PREMATURELY DETACHED. THEY SUCCESSFULLY RECAPTURED THE COIL WITH A SNARE AND COMPLETED THE CASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623769 ↗
• MalfunctionOct 12, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "PHYSICIAN ATTEMPTED TO RETRACT COIL BACK IN TO INTRO SHEATH. HE THOUGHT THE COIL WAS IN THE INTRODUCER THEN FLUSHED THE MICROCATHETER (PROGREAT 2.4),TO WHICH THE COIL WAS PUSHED INTO THE VESSEL. PREMATURE DETACHMENT OCCURRED INSIDE THE MICROCATHETER PRIOR TO EXTRACTION. PHYSICIAN WAS ABLE TO SNARE THE COIL SO NO HARM TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619456 ↗

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-1041-2024 · Jan 3, 2024 · Open, Classified
  Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracra
• 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