PrimeWire Prestige Plus Pressure Guide Wire 185cm ST 9185Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845225001100), received between Aug 28, 2015 and Feb 1, 2017 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

1 other recall cover devices cleared under the same FDA submission (K111395); 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.

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.

• DeathFeb 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. THE CUSTOMER REPORTED THAT AFTER IVUS WAS COMPLETED AND REMOVED, WE [THE PHYSICIAN] INSERTED THE [MANUFACTURERS DEVICE]. HAD DIFFICULTY AT THE LEFT MAIN, AND THEN NOTICED NO FLOW. REMOVED WIRE AND BEGAN CPR, PATIENT EXPIRED 30 MINUTES LATER ON THE PROCEDURE TABLE. PATIENT CONDITION: DEATH. VESSEL DETAILS: MID/DISTAL LAD, 4.2MM TWO (2) AREA PLAQUE BURDEN. IT WAS FURTHER REPORTED THE PATIENT HAD BEEN DIAGNOSED WITH CANCER AND WAS SCHEDULED TO BE SENT FOR TREATMENT. PRE-CANCER TREATMENT LABS REVEALED ELEVATED LEVELS OF TROPONIN. THE PATIENT WAS SENT FOR AN ANGIOGRAM. DURING THE ANGIOGRAM THE PHYSICIAN INSERTED AND REMOVED IVUS CATHETER TO SUCCESSFULLY MEASURE THE PLAQUE BURDEN. WHEN ADVANCING THE MANUFACTURERS DEVICE WITHIN THE GUIDE CATHETER TO MEASURE FFR, PRIOR TO NORMALIZATION, THE PATIENT BEGAN TO CODE. ALL DEVICES WERE REMOVED FROM THE PATIENT AND CPR WAS INITIATED. THIRTY (30) MINUTES LATER THE PATIENT EXPIRED ON THE TABLE. NO DAMAGE WAS OBSERVED DURING PREP. NO RESISTANCE WAS MET AND DEVICE WAS NOT STUCK. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. OTHER DEVICES IN USE: BOSTON S

  Patient problems: Death

  MAUDE report 6294485 ↗
• MalfunctionAug 28, 2015Device Displays Incorrect Message

  PTCI WAS BEING PERFORMED. PRESSURE WIRE GAVE AN ERROR READING. ANOTHER PRESSURE WIRE WAS USED AND IT FUNCTIONED WITHOUT DIFFICULTIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5053584 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111395. One submission often covers many models, so check the product and lot details in each record.

• Z-1845-2015 · Jun 4, 2015 · Terminated
  Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and periphe