TA Premium 015451LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521047389), received between Apr 6, 2018 and Jan 28, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE.

  Patient problems: Insufficient Information

  MAUDE report 11246011 ↗
• MalfunctionDec 20, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A INCARCERATED HERNIA REPAIR WITH A BOWEL RESECTION, WHEN TRANSECTING A PORTION OF BOWEL, THE DEVICE DID NOT FIRE COMPLETELY OR FIRED PARTIALLY. THE STAFF OPENED A SECOND INSTRUMENT AND RELOAD. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9504449 ↗
• InjuryJul 9, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN LOW ANTERIOR RESECTION, ON THE PORTION OF THE RECTUM, THE STAPLES STAYED IN THE DEVICE WHEN FIRED ACROSS THE RECTUM THAT HAPPENED TWICE. THEY REMOVED THE OLD STAPLE LINE AND REAPPLIED THE DEVICE TO COMPLETE THE CASE ON THE THIRD FIRING. THERE WAS AN UNANTICIPATED TISSUE LOSS.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8771416 ↗
• InjuryNov 6, 2018Failure to Align; Failure to Form Staple; Failure to Align; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT OPEN HEMICOLECTOMY PROCEDURE, WHILE TRANSECTING THE RIGHT COLON, THE TIP OF T HE INSTRUMENT DID NOT SEEM TO BE ALIGNING PROPERLY AND THE STAPLE LINE DIDN'T FEEL CORRECT WHEN FIRING OR LOOK CORRECT POST FIRING. THE STAPLE LINE WAS RESECTED AND RE-STAPLED TO RESOLVE THE ISSUE. THE SURGEON HAD TO FREE UP MORE BOWEL TO REDO THE ANASTOMOSIS EXTENDING THE PROCEDURE BY 45 MINUTES.

  Patient problems: No Code Available

  MAUDE report 8042239 ↗
• InjuryApr 6, 2018Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN ANTERIOR RESECTION OF THE RECTUM PROCEDURE, WHILE CLOSING OF THE STUMP, THERE WERE 3 LOADS DID NOT CREATE A CORRECT LINE OF STAPLES ON THE INTESTINE DUE TO A LEAK IN THE INTESTINAL STUMP. THERE WERE 4 ATTEMPTS TO CLOSE THE STUMP SO ANOTHER LOAD FROM ANOTHER PACKAGING WAS USED AND SEWN MANUALLY TO RESOLVE THE ISSUE. A CREATION OF A PERMANENT COLOSTOMY WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF A FUNCTION.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7403299 ↗

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-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-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