PINNACLE 2218-87-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295101956), received between Aug 14, 2018 and Apr 27, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2021Scratched Material; Scratched Material

  IT HAS BEEN BROUGHT TO MY ATTENTION BY MDRD THAT TOTAL 5 OF OUR 36MM TRIAL LINERS HAVE SUFFERED SOME WEAR AND TEAR. THERE ARE GOUGES IN THE MATERIAL AND THEREFORE SITE WILL NOT STERILIZE AND REPROCESS THESE TRIAL LINERS. THREE OF THE LINERS ARE DOWNSTAIRS AND WILL HAVE TO CONFIRM WHICH THREE THOSE ARE. AS FOR THE MISSING OTHER 2 THE LEAD OF MDRD IS CERTAIN THEY GAVE THEM TO ONE OF OUR SALES TEAMMATES BUT HAVE NOT BEEN ABLE TO LOCATE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732171 ↗
• MalfunctionApr 27, 2021Scratched Material; Scratched Material

  IT HAS BEEN BROUGHT TO MY ATTENTION BY MDRD THAT TOTAL 5 OF OUR 36MM TRIAL LINERS HAVE SUFFERED SOME WEAR AND TEAR. THERE ARE GOUGES IN THE MATERIAL AND THEREFORE SITE WILL NOT STERILIZE AND REPROCESS THESE TRIAL LINERS. THREE OF THE LINERS ARE DOWNSTAIRS AND WILL HAVE TO CONFIRM WHICH THREE THOSE ARE. AS FOR THE MISSING OTHER 2 THE LEAD OF MDRD IS CERTAIN THEY GAVE THEM TO ONE OF OUR SALES TEAMMATES BUT HAVE NOT BEEN ABLE TO LOCATE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732168 ↗
• MalfunctionFeb 16, 2021Scratched Material; Scratched Material

  LINER TRIALS WERE FOUND TO HAVE DEEP GOUGES THAT WERE HARD TO CLEAN AND WERE REJECTED BY THE MEDICAL DEVICE REPROCESSING DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334665 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038315 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038273 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038250 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038235 ↗
• MalfunctionAug 14, 2018Break; Break

  INSTRUMENTS ARE BROKEN AND NEED TO BE REPLACED. NOTHING FELL INTO PATIENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. ONE OF EACH IMPACTED, ONE OF EACH NEEDING REPLACEMENT. NO CHARGE REPLACEMENT (B)(4). (B)(6). PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 7781615 ↗