PROCEED PCDH1Recalls & reported problems

Summary

The FDA's MAUDE database contains 421 adverse event reports that list this exact device (DI 10705031047723), received between Sep 3, 2015 and Jan 26, 2026 — classified as 418 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (11 reports).

3 other recalls cover devices cleared under the same FDA submission (K060713); they may or may not involve this specific model.

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

Recent adverse event reports

The 25 most recent of 421 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND ADHESION NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 24183132 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION OF RIGHT ABDOMINAL WALL. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 24137038 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND TWO (2) MESH WERE IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 22881831 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT ANOTHER HERNIA REPAIR SURGERY ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. IT WAS REPORTED THAT PREVIOUSLY THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2008 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD VENTRAL LAPAROSCOPIC HERNIA REPAIR SURGERY ON (B)(6) 2010 AND A MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 22686135 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2008 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22584006 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA AND A MESH WAS IMPLANTED ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, SMALL BOWEL OBSTRUCTION, ADHESIONS, DEHISCENCE, AND SEROSAL EXCORIATION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Obstruction/Occlusion; Pain

  MAUDE report 22493577 ↗
• MalfunctionJun 26, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND MESH WAS USED. MESH SHRINKAGE ISSUE WAS NOTED. DURING INTRA OPERATIVE PROCEDURE, SURGEON FOUND SOME BULGES AND SHRINKAGE IN THE MESH IN 3-4 AREAS IN THE MIDDLE AND HE DIDN'T USE THE MESH OUT OF CARE FOR PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341653 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT LEFT LOWER QUADRANT VENTRAL HERNIA REPAIR SURGERY (B)(6) 2010 AND MESH AND 2 (TWO) MESH WERE IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY AND MULTIPLE REVISIONARY SURGERIES. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22312856 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND ABDOMINAL WALL CELLULITIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Cellulitis

  MAUDE report 22060475 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2013 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22058914 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL HERNIA AND MESH WAS IMPLANTED ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22043924 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR AND MESH WAS IMPLANTED ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22034625 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL INCISIONAL HERNIA AND TWO (2) MESH WAS IMPLANTED ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22000418 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF INCARCERATED RECURRENT VENTRAL HERNIA ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 21982154 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD UMBILICAL INCISIONAL HERNIA PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s)

  MAUDE report 21967087 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED FEVER, CHILLS, SWEATS AND URINARY TRACT INFECTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Chills; Diaphoresis; Fever; Urinary Tract Infection

  MAUDE report 21940433 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2014 AND A MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2014 AND A MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21906598 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 AND MESH WAS IMPLANTED DUE TO HERNIA RECURRENCE. IT WAS REPORTED THAT PATIENT HAD HERNIA REPAIR SURGERY LAST (B)(6) 2006 AND MESH WAS IMPLANTED AND REVISION LAST 1/16/2009 AND MESH WAS IMPLANTED AND ANOTHER REVISION SURGERY LAST (B)(6) 2018. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21906087 ↗
• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA ON (B)(6) 2016 AND TWO MESHES WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL SURGERY ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED THERE WAS SOME SIGNIFICANT AMOUNT OF BOWEL THAT WAS SCARRED IN WITH THE MESH. AS THIS ALREADY CONTAINED AN ENTEROTOMY FROM ITS ADHERENCE TO THE MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS, NAUSEA, VOMITING AND ABDOMINAL PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Nausea; Scar Tissue; Vomiting

  MAUDE report 21845694 ↗
• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA ON (B)(6) 2016 AND TWO MESHES WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL SURGERY ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED THERE WAS SOME SIGNIFICANT AMOUNT OF BOWEL THAT WAS SCARRED IN WITH THE MESH. AS THIS ALREADY CONTAINED AN ENTEROTOMY FROM ITS ADHERENCE TO THE MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS, NAUSEA, VOMITING AND ABDOMINAL PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Nausea; Scar Tissue; Vomiting

  MAUDE report 21845692 ↗
• InjuryApr 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA SURGERY ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EVISCERATION, DEHISCENCE AND PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Perforation; Wound Dehiscence

  MAUDE report 21782739 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA AND A MESH WAS IMPLANTED ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21759233 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT INCARCERATED INCISIONAL HERNIA REPAIR ON (B)(6)2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21640021 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2010 AND 2 MESHES WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2010. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT LOWER QUADRANT PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 21570247 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2010 AND 2 MESHES WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2010. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT LOWER QUADRANT PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia; Pain

  MAUDE report 21570244 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060713. One submission often covers many models, so check the product and lot details in each record.

• Z-0533-2021 · Oct 23, 2020 · Terminated
  PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
• Z-1329-2014 · Feb 19, 2014 · Open, Classified
  Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that r
• Z-0903-2011 · Oct 18, 2010 · Open, Classified
  PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company. Used for the repair of hernias and other fascial deficiencies that require the a