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Amplatz G53564Recalls & reported problems

Cook Incorporated · Amplatz Extra Stiff Fixed Core Wire Guide Double Flexible · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002535640), received between Feb 8, 2017 and Feb 8, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unraveled Material” (1 report).

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.

Most reported problems

Device problems

  • Unraveled Material1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 8, 2017Unraveled Material; Unraveled Material

    IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE USING A AMPLATZ EXTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE. THE ATTENDING PHYSICIAN INDICATED THAT THE WIRE BECAME UNRAVELED WHILE REMOVING THE DEVICE FROM THE PATIENT. THE PHYSICIAN STATED THE TIP IS MISSING AND IS UNCERTAIN IF THE TIP OR COATING WAS LEFT INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6310383 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.