PINNACLE 2217-01-053Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295097648), received between Aug 19, 2020 and Jun 21, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED AS "CAN¿T READ SIZES ON TRIALS (WORN OFF). SEND REPLACEMENTS TO (B)(6)." NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036339 ↗
• MalfunctionJun 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED AS "CAN¿T READ SIZES ON TRIALS (WORN OFF). SEND REPLACEMENTS TO (B)(6)." NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036321 ↗
• MalfunctionJun 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED AS "CAN'T READ SIZES ON TRIALS (WORN OFF). SEND REPLACEMENTS TO (B)(6)." NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036290 ↗
• 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 12034949 ↗
• 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 12034458 ↗
• 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 12034370 ↗
• MalfunctionAug 19, 2020Material Twisted/Bent; Naturally Worn; Illegible Information; Material Twisted/Bent; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE SIZING ON THE TRIALS CAN'T BE READ. NUMBER ETCHING WERE WORN OFF. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR SURGICAL DELAYS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10426866 ↗