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
- Bioinductive Implant with Arthroscopic Delivery System - Large 4566Smith & Nephew, Inc. · Mesh, Surgical, Deployer24 reports
- Bioinductive Implant with Arthroscopic Delivery System - Medium 4565Smith & Nephew, Inc. · Mesh, Surgical, Deployer24 reports
- VENTRALIGHT 5991520Davol Inc. · Mesh, surgical, deployer12 reports
- Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Medium 2169-2Smith & Nephew, Inc. · Mesh, Surgical, Deployer4 reports
- AccuMesh AMPMEDCovidien LP · Mesh, surgical, deployer2 reports
- Phasix 1212025Davol Inc. · Mesh, surgical, deployer1 report
- Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Large 2169-3Smith & Nephew, Inc. · Mesh, Surgical, Deployer1 report
- AccuMesh AMPPCO15XCovidien LP · Mesh, surgical, deployer1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.