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AccuMesh AMPPCO2015XRecalls & reported problems

Covidien LP · Mesh Positioning System · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521174689), received between Jan 22, 2020 and Jan 22, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Material Deformation1
  • Migration or Expulsion of Device1

Patient problems

  • Abdominal Pain1
  • Adhesion(s)1
  • Ambulation or Postural Difficulties1
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Discomfort1
  • Hernia1
  • Injury1
  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 22, 2020Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, MASSIVE DILATED JEJUNUM, SMALL BOWEL TORSION, MESH PULLED AND MESH DETACHMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND BOWEL RESECTION.

    Patient problems: Abdominal Pain; Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Injury; No Code Available; Obstruction/Occlusion; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

    MAUDE report 9616998 ↗

Other Mesh, surgical, deployer devices

All Mesh, surgical, deployer devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.