TA Premium 015485LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521047433), received between Aug 17, 2018 and Jul 13, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Form Staple” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K855047); 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. How this data works · Data updated Oct 13, 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.

• InjuryJul 13, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN COLORECTAL PROCEDURE, ON STAPLER APPLICATION, ONLY HALF OF THE STAPLE LINE FIRED. THERE WAS AN UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE. THE SURGEON TRIED MAKE AN ANASTOMOSIS AFTER THE EVENT BUT THE PATIENT REQUIRED AN OSTOMY BAG TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10264820 ↗
• InjuryAug 17, 2018Failure to Form Staple; Difficult to Open or Close; Failure to Form Staple; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A MECHANICAL ANASTOMOSIS ON AN OPEN PROCEDURE, THE DEVICE WAS DIFFICULT OR UNABLE TO CLOSE. THE DEVICE ALSO HAD AN INCOMPLETE STAPLE LINE. THEY HAD TO OVERSEW TO FIX THE STAPLE LINE AND ANOTHER MECHANICAL ANASTOMOSIS WAS DONE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 7793341 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K855047. One submission often covers many models, so check the product and lot details in each record.

• Z-1845-2012 · May 9, 2012 · Terminated
  Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection
• Z-1844-2012 · May 9, 2012 · Terminated
  Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection,
• Z-1846-2012 · May 9, 2012 · Terminated
  Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection
• Z-1847-2012 · May 9, 2012 · Terminated
  Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection
• Z-1848-2012 · May 9, 2012 · Terminated
  Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection,