Prestige Coil System PRES0750HPKPLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810068567861), received between Dec 27, 2024 and Dec 27, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature Separation” (1 report).

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

1 other recall cover devices cleared under the same FDA submission (K220699); 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 ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "PRES0750HPKPL WAS DEPLOYED INTO A SPLENIC ARTERY AND WOULD NOT DETACH. 10 PLUS ATTEMPTS WERE MADE AND SECOND DETACHMENT HANDLE TO NO AVAIL. THE COIL WAS RETRACTED. DURING THE COIL BEING REMOVED IT PREMATURELY DETACHED AND SNAPPED HALF WAY DOWN THE IMPLANT. THE REST OF THE COIL IN THE MICROCATHETER WAS ATTEMPTED TO BE PUSHED IN WITH A COIL PUSHER AND WAS ULTIMATELY FLUSHED IN TO FINISH THE CASE." UPDATE 02DEC2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1) WAS ANY OF THE IMPLANT PROTRUDING OUT OF THE MC WHEN THE DETACHMENT HAPPENED? YES, THE COIL WAS BEING RETRACTED AND WAS HALF IN THE MC AND HALF IN THE VESSEL WHEN THE DETACHMENT HAPPENED. 2) WAS ANY ADDITIONAL DEVICES USED IN ORDER TO MOVE/RETRIEVE THE IMPLANT COIL? YES, THEY DID OPEN A COIL PUSHER TO TRY TO PUSH THE COIL THE REST OF THE WAY IN, HOWEVER IT DIDN'T WORK AND THAT IS WHY THE CHOSE TO FLUSH THE COIL IN. 3) WAS THERE ANY IMPACT TO THE PATIENT FOLLOWING THE IMPLANT COIL BEING FLUSHED INTO THE TREATMENT LOCATION? YES, THE EMBOLIZATION WAS OFF TARGET. LUCKILY, IT WAS NOT IN THE PARENT VESSEL, SO IN THIS CASE A SLIGHTLY OFF TARGET EMBOLIZATION WAS STILL ACCEPTABLE." INCIDENT REPORT FORM SUB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027267 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K220699. One submission often covers many models, so check the product and lot details in each record.

• Z-1042-2024 · Jan 3, 2024 · Open, Classified
  The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to em