ARTISYN ARTY (UDI 10705031202795)Recalls & reported problems
Johnson & Johnson Medical GmbH · Artisyn Y-Shaped Mesh · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031202795), received between Oct 5, 2018 and Feb 6, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
- Migration1
Patient problems
- Erosion1
- No Clinical Signs, Symptoms or Conditions1
- Not Applicable1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND MESH WAS USED. BREAKAGE INTERFACE MESH. SURGERY WAS PERFORMED UNDER THE MICROSCOPE, AND DURING THE OPERATION, IT WAS FOUND THAT THE INTERFACE MESH WAS BROKEN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280393 ↗InjuryOct 5, 2018Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNCOMPLICATED SACROCOLPOPEXY SURGERY IN (B)(6) 2016 AND THE MESH WAS IMPLANTED. AT THE 3 MONTHS POST-OP, A LITTLE MESH EXPOSURE WAS FOUND ON THE RIGHT SIDE OF THE VAGINAL TOP. IT WAS ALSO REPORTED THAT FIRST THE PATIENT WAS WAITING WITH TREATMENT, BUT WHEN PATIENT CAME FOR CONTROL IN (B)(6) 2018, THE PATIENT WANTED TO HAVE THE MESH EXPOSURE REMOVED. THE MESH EXPOSURE REMOVAL WAS PERFORMED ON (B)(6) 2018. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Erosion; Not Applicable
MAUDE report 7941082 ↗
Other Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed devices
- GYNECARE GYNEMESH GPSLEthicon, LLC · Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed164 reports
- Upsylon™ M0068318200Boston Scientific Corporation · Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed126 reports
- Alyte™ Y-Mesh Graft Y100C. R. Bard, Inc. · Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed1 death84 reports
- Alyte™ Y-Mesh Graft Y500C. R. Bard, Inc. · Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed76 reports
- Restorelle 501420Coloplast A/S · Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed40 reports
- Restorelle 501520Coloplast A/S · Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed25 reports
- ARTISYN ARTYJohnson & Johnson International Inc. · Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed21 reports
- GYNECARE GYNEMESH GPSXL3Ethicon, LLC · Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed17 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.