TA Premium 015458LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521047402), received between Mar 27, 2018 and Jan 9, 2019 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN LOW ANTERIOR RESECTION PROCEDURE, SMALL BLEEDING WAS OBSERVED BUT, IT WAS NOT SURE IF IT CAME FROM THE STAPLE LINE. A DRAINAGE WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 8231764 ↗
• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN LOW ANTERIOR RESECTION, A SMALL BLEEDING WAS NOTICED. IT WAS UNSURE IF THE BLEEDING WAS FROM THE STAPLE LINE. THEY WANTED TO CHECK SOMEONE ELSE HAD SAME PROBLEM WITH THE SAME RELOAD AND SAME LOT NUMBER. DRAINAGE WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 8231395 ↗
• InjuryNov 2, 2018Loss of or Failure to Bond; Misfire; Failure to Form Staple; Loss of or Failure to Bond; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING PNEUMONECTOMY, THE DEVICE WAS PARTIALLY FIRED AND THERE WAS A POOR STAPLE FORMATION. AFTER THE SUR GICAL PROCEDURE DURING THE BRONCHOSCOPY, PHYSICIAN FOUND OUT THAT STAPLER LINE WAS PARTIALLY OPEN. THE PATIENT WAS UNDER 24 HOUR OBSERVATION AND CURRENTLY HOSPITALIZED AT THE INTENSIVE CARE DEPARTMENT.

  Patient problems: No Code Available

  MAUDE report 8033252 ↗
• InjuryMar 27, 2018Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING OPEN RECTUM SURGERY, THE STAPLES DID NOT DEPLOY AT THE END OF THE PROCEDURE. THERE WAS ALSO POOR STAPLE FORMATION. THE STAPLE LINE WAS FIXED BY OVER SEW AND COLOSTOMY WAS DONE IN ORDER TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 7374342 ↗

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-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-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-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,
• 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-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