PINNACLE 2217-01-045Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295097563), received between Mar 23, 2021 and Jun 21, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. 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.

• MalfunctionJun 21, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED AS "CAN¿T READ SIZES ON TRIALS (WORN OFF). NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12034808 ↗
• MalfunctionMar 23, 2021Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  COMPLAINT FROM THE STERILE DEPARTMENT DUE TO CORROSION ON CE MARKING OR NUMBERS. LOOKS LIKE CORROSION ON MARKINGS, BROWNISH COLOR! NO NEW PROCEDURES IN STERILE DEPART, NO NEW CHEMICALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556698 ↗