AccuMesh AMPPCO15XRecalls & 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 10884521174696), received between May 18, 2021 and May 18, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
- Patient Device Interaction Problem1
Patient problems
- Abscess1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Ascites1
- Erosion1
- Fluid Discharge1
- Hernia1
- Inflammation1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED EROSION, ABDOMINAL MASS, MIGRATION, INFLAMMATION, SPACE FILLED WITH FLUID, ABSCESS, INFECTION, RECURRENCE, SEROSANGUINEOUS FLUID, SWELLING, SEROUS FLUID, AND WOUND DRAINAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH/MASS, HERNIA REPAIR WITH NEW MESH, EVACUATION OF SEROSANGUINEOUS FLUID, ADMISSION TO HOSPITAL, AND MESH DISSECTION.
Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Erosion; Fluid Discharge; Hernia; Inflammation; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 11844813 ↗
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
- AccuMesh AMPPCO2015XCovidien LP · Mesh, surgical, deployer1 report
- Phasix 1212025Davol Inc. · Mesh, surgical, deployer1 report
- Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Large 2169-3Smith & Nephew, Inc. · Mesh, Surgical, Deployer1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.