Appose ULCRecalls & reported problems across all models

We found 2 models of Appose ULC by Covidien LP in the FDA's device registry (GUDID). Together they are named in 134 adverse event reports in the FDA's MAUDE database, received between Jul 8, 2016 and Sep 28, 2026 — classified as 18 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (55 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Appose ULC problems

Appose ULC models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Appose ULC 8886803712

  STAPLE, REMOVABLE (SKIN)
  68 reports
• Appose ULC 8886803512

  STAPLE, REMOVABLE (SKIN)
  66 reports

Recent Appose ULC adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923742 ↗
• MalfunctionAug 6, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  Patient problems: Laceration(s)

  MAUDE report 50161193 ↗
• MalfunctionMay 19, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE STAPLES DID NOT CLOSE PROPERLY FOR THE THREE SKIN STAPLERS. ABSORBABLE SUTURE WAS USED IN ORDER TO CLOSE THE WOUND AND COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25224597 ↗
• MalfunctionMay 19, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE STAPLES DID NOT CLOSE PROPERLY FOR THE THREE SKIN STAPLERS. ABSORBABLE SUTURE WAS USED IN ORDER TO CLOSE THE WOUND AND COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25224563 ↗
• MalfunctionApr 28, 2026Failure to Align; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER INTRA-OPERATIVELY, THE STAPLER MISFIRED AND WAS NOT ALIGNED PROPERLY DURING FIRING WHICH CAUSED TISSUE DAMAGE TO THE PATIENT. THE DEVICE USE WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 25011819 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A PATIENT UNDERWENT A CESAREAN SECTION CLOSED WITH A SKIN STAPLER, THE PATIENT DEVELOPED A LOCALIZED POSTOPERATIVE WOUND COMPLICATION CHARACTERIZED BY A SLIGHTLY INFLAMMATORY, WARM BUT PAINLESS NECROTIC AREA (5 CM) AT THE CENTER OF THE SURGICAL SCAR, ALONG WITH A BLISTER AND THE RELEASE OF FOUL-SMELLING SEROSANGUINOUS FLUID FOLLOWING REMOVAL OF TWO STAPLES. THE ADVERSE EVENT REQUIRED SURGICAL INTERVENTION UNDER GENERAL ANESTHESIA, INCLUDING WIDE EXCISION OF NECROTIC TISSUE (2 CM MARGIN) AND DEBRIDEMENT TO HEALTHY TISSUE, FOLLOWED BY TRIPLE ANTIBIOTIC THERAPY, MICROBIOLOGY CULTURES WERE POSITIVE FOR STREPTOCOCCUS ORALIS/MITIS AND STAPHYLOCOCCUS EPIDERMIDIS. SUBSEQUENT MONITORING SHOWED PERSISTENT INFLAMMATION, ELEVATED C-REACTIVE PROTEIN (CRP), AND IMAGING FINDINGS OF A SMALL HYDROAERIC COLLECTION IN THE ABDOMINAL WALL, LEADING TO ADJUSTMENT OF ANTIBIOTIC THERAPY AND CONTINUED CLINICAL OBSERVATION, WITH INVOLVEMENT OF THE HOSPITAL HYGIENE SERVICE FOR INFECTION ANALYSIS.

  Patient problems: Fluid Discharge; Local Reaction; Necrosis; Skin Inflammation/ Irritation; Unintended Radiation Exposure; Unspecified Infection; Wound Odor

  MAUDE report 24911482 ↗
• MalfunctionMar 25, 2026Material Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, IMMEDIATELY AFTER THE SQUEEZE, THE STAPLES BROKE INSIDE THE DEVICE, WHICH SUBSEQUENTLY CAUSED THE JAMMING OF THE MECHANISM. ANOTHER SAME TYPE OF DEVICE FROM THE SAME COMPANY WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24692042 ↗
• MalfunctionFeb 12, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE STAPLES FROM THE SKIN STAPLER DID NOT HOLD. THE PATIENT HAD TO TRANSFER TO ANOTHER CLINIC TO REPLACE THE STAPLES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24327788 ↗
• MalfunctionJan 15, 2026Unintended Ejection; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENTS DEVELOPED WOUND DEHISCENCE BECAUSE THE SKIN STAPLES WERE RELEASED TOO EARLY.

  Patient problems: Wound Dehiscence

  MAUDE report 24079942 ↗
• MalfunctionJan 15, 2026Unintended Ejection; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENTS DEVELOPED WOUND DEHISCENCE BECAUSE THE SKIN STAPLES WERE RELEASED TOO EARLY.

  Patient problems: Wound Dehiscence

  MAUDE report 24079919 ↗
• MalfunctionJan 2, 2026Entrapment of Device; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PARTIAL MASTECTOMY PROCEDURE, IN SKIN CLOSURE, A PARTIALLY DEPLOYED STAPLE WAS STUCK AT THE END OF THE STAPLER AND WAS CAUGHT ON TISSUE. THIS RESULTED IN SKIN DAMAGE. TO RESOLVE THE ISSUE, A NEW STAPLER OF THE SAME TYPE WAS USED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23951001 ↗
• InjuryDec 16, 2025Entrapment of Device; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POSTOPERATIVELY, THE STAPLES WERE PARTIALLY DEPLOYED BUT WERE STUCK IN THE END OF THE STAPLER. THE PATIENT HAD TO COME TO THE EMERGENCY ROOM ON (B)(6) 2024, BECAUSE IT WAS NOT POSSIBLE FOR THE PRIVATE NURSE TO REMOVE THE STAPLES. THE PATIENT EXPERIENCED INTENSE PAIN WHEN THE STAPLES WERE REMOVED AND HAD SKIN LESIONS RELATED TO THE REMOVAL OF STAPLES. ACTIONS WERE TAKEN IN THE HEALTHCARE FACILITY FOR THE MANAGEMENT OF THE PATIENT.

  Patient problems: Localized Skin Lesion; Pain

  MAUDE report 23821090 ↗
• MalfunctionDec 12, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE SKIN STAPLER, THE DEVICE WAS ACTIVATED AND THE STAPLES WERE DEPLOYED; HOWEVER, THE STAPLES FAILED TO PROPERLY ENGAGE OR PENETRATE THE SKIN, RESULTING IN THE WOUND REMAINING OPEN. THE DEVICE MALFUNCTION REQUIRED ADDITIONAL MANIPULATION OF THE WOUND, AND EXTENDED THE SURGERY TIME. ANOTHER SAME TYPE OF DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23786527 ↗
• MalfunctionNov 11, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING USE OF THE SKIN STAPLER, THE DEVICE DID NOT TRIGGER THE STAPLE CORRECTLY AND REMAINED STUCK TO THE SKIN. THE STAPLER WAS CHANGED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529227 ↗
• MalfunctionOct 22, 2025Material Separation; Failure to Form Staple; Material Separation; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCEDURE, AT SKIN CLOSURE, THE STAPLE BROKE, AND A STAPLE WENT INSIDE WITHOUT BEING CAUGHT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358983 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall