PROLITE 1010202-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00650862301021), received between Jan 30, 2019 and Sep 21, 2020 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K151437, K930669); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED UNSPECIFIED INJURIES AND COMPLICATIONS AS A RESULT OF THE IMPLANTATION OF THE MESH IMPLANT. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

  Patient problems: No Information

  MAUDE report 10564699 ↗
• InjuryJul 10, 2020Patient-Device Incompatibility

  THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED UNSPECIFIED INJURIES AND COMPLICATIONS AS A RESULT OF THE IMPLANTATION OF THE MESH IMPLANT. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/ CLIENT AND/ OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

  Patient problems: No Information

  MAUDE report 10261663 ↗
• InjuryMay 4, 2020Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED UNSPECIFIED INJURIES AND COMPLICATIONS AS A RESULT OF THE IMPLANTATION OF THE MESH IMPLANT. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/ CLIENT AND/ OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

  Patient problems: No Information

  MAUDE report 10022951 ↗
• MalfunctionNov 26, 2019Adverse Event Without Identified Device or Use Problem

  N/A

  Patient problems: Impotence

  MAUDE report 9376250 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT THAT STATES THERE IS BLOCKAGE/DESTRUCTION OF THE VAS DEFERENS DUE TO SCAR TISSUE FROM THE PROLITE MESH. FOLLOWING A SPERM ASPIRATION PROCEDURE, IT WAS DETERMINED THAT THE PATIENT DOES HAVE VIABLE SPERM IN THE TESTICLES, HOWEVER, THE BLOCKAGE/DESTRUCTION IS RESULTING IN A ZERO SPERM COUNT.

  Patient problems: Impotence

  MAUDE report 9340258 ↗
• MalfunctionJan 30, 2019Detachment of Device or Device Component

  RECEIVED A CALL FROM A HOSPITAL THAT THE SURGEON WAS DOING A HERNIA REPAIR AND USING THE TAB AS AN ANCHOR. THE TAB PULLED OFF. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290579 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151437, K930669. One submission often covers many models, so check the product and lot details in each record.

• Z-0712-2018 · Nov 22, 2017 · Terminated
  ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstr