Prestige Coil System PRES0103CXPPLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053027277), received between Oct 20, 2023 and Oct 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2023 IT WAS DISCOVERED THAT THE RETAIN LABEL WITHIN THE LHR OF A LOT UNDERGOING QC INSPECTION CALLED OUT THE INCORRECT DIMENSION UNDER DIMENSION D ON THE PRESTIGE COIL SYSTEM LABEL. DIMENSION D IS THE MEASUREMENT OF THE FIRST LOOP DIAMETER.DIMENSION D SHOULD STATE 1 MM FOR MODEL PRES0103CXPPL, HOWEVER IT STATES 3CM. FOLLOWING THIS DICOVERY AT QC, BUILD RECORDS WERE REVIEWED SINCE THE POINT AT WHICH THE ERROR IN THE LABELING DATABASE WOULD HAVE BEEN ACTIVE AND THERE WERE 2 LOTS IDENTIFIED TO HAVE BEEN BUILT AND RELEASED (LOT #F220701373 (18 UNITS) AND LOT #F220701428 (13 UNITS)) WITH THE SAME DISCREPANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981276 ↗
• MalfunctionOct 20, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2023 IT WAS DISCOVERED THAT THE RETAIN LABEL WITHIN THE LHR OF A LOT UNDERGOING QC INSPECTION CALLED OUT THE INCORRECT DIMENSION UNDER DIMENSION D ON THE PRESTIGE COIL SYSTEM LABEL. DIMENSION D IS THE MEASUREMENT OF THE FIRST LOOP DIAMETER. DIMENSION D SHOULD STATE 1 MM FOR MODEL PRES0103CXPPL, HOWEVER IT STATES 3CM. FOLLOWING THIS DISCOVERY AT QC, BUILD RECORDS WERE REVIEWED SINCE THE POINT AT WHICH THE ERROR IN THE LABELING DATABASE WOULD HAVE BEEN ACTIVE AND THERE WERE 2 LOTS IDENTIFIED TO HAVE BEEN BUILT AND RELEASED (LOT #F220701373 ((B)(4) UNITS) AND LOT #F220701428 ((B)(4) UNITS)) WITH THE SAME DISCREPANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981275 ↗

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