PROCEED PCDN1Recalls & reported problems

Summary

The FDA's MAUDE database contains 744 adverse event reports that list this exact device (DI 10705031047761), received between Jan 9, 2018 and May 5, 2026 — classified as 737 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Migration” (17 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 744 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY OF PREVIOUSLY PLACED MESH ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2019 DURING WHICH THE SURGEON NOTED THE MESH TO BE ESSENTIALLY FROZEN WITH ADHESIONS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DENSE ADHESIONS, SMALL BOWEL OBSTRUCTIONS, INFECTIONS, NAUSEA, VOMITING, CHRONIC INTRACTABLE ABDOMINAL PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Nausea; Obstruction/Occlusion; Unspecified Infection; Vomiting

  MAUDE report 25077663 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 24240769 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2021 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24225214 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2019 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24198783 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2012 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24182984 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2024 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ERYTHEMA, EPIDERMAL SLOUGHING, TENDERNESS AND ABDOMINAL WALL ABSCESS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erythema; Peeling

  MAUDE report 24171106 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT UMBILICAL HERNIA PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24145376 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2018 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023 DUE TO PAIN, HERNIA RECURRENCE AND ADHESION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 24072593 ↗
• InjuryDec 5, 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 A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED TENDERNESS AND ABDOMINAL PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23733167 ↗
• InjuryNov 26, 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 OPEN INCISIONAL HERNIA REPAIR AND MESH WAS IMPLANTED ON (B)(6) 2016. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD VENTRAL HERNIA REPAIR AND MESH WAS IMPLANTED ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23663129 ↗
• InjuryNov 26, 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 VENTRAL HERNIA REPAIR AND A MESH WAS IMPLANTED ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR AND A MESH WAS IMPLANTED ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23663124 ↗
• InjuryOct 30, 2025Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY OF PREVIOUSLY PLACED MESH ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 23430831 ↗
• InjuryOct 20, 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 A VENTRAL HERNIA REPAIR ON (B)(6) 2008 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCARCERATED SMALL BOWEL, EXHIBITING EVIDENCE OF EDEMA AND MESENTERIC CONGESTION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema

  MAUDE report 23338798 ↗
• InjuryAug 26, 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 UNDERWENT REVISION SURGERY ON (B)(6) 2010. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 22893927 ↗
• InjuryAug 26, 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) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22893875 ↗
• 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 22881832 ↗
• InjuryAug 14, 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 7/22/2014 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND HERNIA RECURRENCE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Hernia; Pain

  MAUDE report 22801996 ↗
• InjuryAug 8, 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 UMBILICAL HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD 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: Insufficient Information

  MAUDE report 22752997 ↗
• InjuryAug 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 INCISIONAL HERNIA REPAIR ON (B)(6) 2015 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22725820 ↗
• InjuryAug 5, 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 RECURRENT VENTRAL HERNIA REPAIR ON (B)(6) 2017 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22715658 ↗
• InjuryAug 4, 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 PARASTOMAL AND INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2009 AND TWO (2) MESH WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION 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 ADHESION AND PAIN. OTHER PROCEDURE WAS CAPTURED ON A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 22710559 ↗
• InjuryAug 4, 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 PARASTOMAL AND INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2009 AND TWO (2) MESH WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION 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 ADHESION AND PAIN. OTHER PROCEDURE WAS CAPTURED ON A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 22700088 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PARASTOMAL AND INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2009 AND TWO (2) MESH WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION 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 ADHESION AND PAIN. OTHER PROCEDURE WAS CAPTURED ON A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 22700077 ↗
• InjuryAug 4, 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 PARASTOMAL AND INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2009 AND TWO (2) MESH WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION 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 ADHESION AND PAIN. OTHER PROCEDURE WAS CAPTURED ON A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 22700075 ↗
• InjuryAug 4, 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 VENTRAL HERNIA REPAIR AND A MESH WAS IMPLANTED ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22696992 ↗

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