ProGrip LPG1612ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521513235), received between Jul 8, 2019 and May 28, 2026 — classified as 13 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (6 reports).

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC INGUINAL HERNIA REPAIR USING A ROBOTIC TRANSABDOMINAL PREPERITONEAL(TAPP) APPROACH, AFTER INSERTION INTO THE PATIENT, THE MESH RIPPED WHILE BEING UNFOLDED DURING MESH DEPLOYMENT. IT WAS REPORTED THAT A DEVICE COMP ONENT FELL INTO THE PATIENT'S CAVITY. THE MESH WAS REMOVED FROM THE BODY CAVITY AND A NEW MESH WAS PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25325301 ↗
• MalfunctionApr 1, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A ROBOTIC INGUINAL HERNIA PROCEDURE, UPON OPENING THE PACKAGE, THE MESH WAS TORN. THE MESH WAS REPLACED WITH ANOTHER PRODUCT. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755718 ↗
• MalfunctionMar 31, 2026Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED HERNIA PROCEDURE, THE SURGEON MISHANDLED THE SPECIMEN, CAUSING IT TO TEAR WHILE USING THE ROBOTIC ARM.

  Patient problems: Insufficient Information

  MAUDE report 24741852 ↗
• InjuryJan 23, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, MESH MIGRATION, NERVE DAMAGE, PAIN, SUFFERING, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL AND NEURECTOMY.

  Patient problems: Adhesion(s); Distress; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 24167028 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A LEFT SIDED SCROTAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury

  MAUDE report 24121839 ↗
• InjuryNov 17, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, INCARCERATED HERNIA, MESH MIGRATION, CONSTIPATION, CRAMPS, INTESTINE STRANGULATION, INTESTINE TANGLED IN MESH AND TESTICULAR PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY AND MEDICATION.

  Patient problems: Adhesion(s); Constipation; Cramp(s) /Muscle Spasm(s); Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 23575628 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, HYDROCELE, MASS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, RECURRENCE, CORD LIPOMA, AND ERECTILE DYSFUNCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED LEFT GROIN EXCISION OF TUMOR, REVISION SURGERY, AND MEDICATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Erectile Dysfunction; Hernia; Inflammation; Nodule; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 22709594 ↗
• InjuryJul 30, 2025Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, MESH CONTRACTION, MESH FOLDING, MESH FAILURE, RECURRENCE, PAIN, DISCOMFORT, EMOTIONAL HARM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, MEDICATION.

  Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22666573 ↗
• InjuryJan 7, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Adhesion(s); Cramp(s) /Muscle Spasm(s); Emotional Changes; Fecal Incontinence; Hemorrhage/Blood Loss/Bleeding; Hernia; Muscle Weakness/Atrophy; Nerve Damage; Numbness; Pain; Sleep Dysfunction; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 21094336 ↗
• MalfunctionAug 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO A ROBOTIC INGUINAL HERNIA PROCEDURE, AFTER OPENING THE PACKAGE, THE SURGEON FOUND OUT THAT THE MESH WAS DAMAGED. THE SEWING APPEARED TO CAUSE A DEFECT AND CLAIMED THE "WEAVING" WAS OFF ON THE MESH. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945486 ↗
• InjuryJul 30, 2024Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 19863557 ↗
• MalfunctionJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A CLINICAL STUDY, 12 MONTHS AFTER AN OPEN LEFT HEMICOLECTOMY PROCEDURE, THE PATIENT HAD A M2W1 INCISIONAL HERNIA THAT WAS DIAGNOSED UNDER ULTRASOUND. THE SIZE OF THE HERNIA WAS SIX MILLIMETERS (6MM) IN LENGTH BY FOUR MILLIMETERS (4 MM) IN WIDTH. IT WAS NOTED THAT THERE WAS NO TREATMENT RESPONSE FOR THE ADVERSE EVENT. THERE WAS NO CLINICAL HERNIA DURING THE EXPLORATION; THE PATIENT WAS ASYMPTOMATIC. THE INVESTIGATOR'S ASSESSMENT WAS NOT RELATED TO THE STUDY PROCEDURE, DEVICE, OR OUTSIDE STANDARD OF CLEAN IN PLACE (CIP) PROCEDURE BUT PROBABLY RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE SPONSOR ASSESSMENT WAS NOT RELATED TO THE STUDY PROCEDURE, TO AN OUTSIDE STANDARD OF CLEAN IN PLACE (CIP) PROCEDURE, BUT WAS POSSIBLE RELATED TO THE DEVICE AND AN UNDERLYING CONDITION OR DISEASE. IT WAS NOTED THAT THE PLACEMENT OF THE MESH TRIED TO REDUCE THE ADVERSE EVENT BUT COULD NOT BE ZERO DUE TO OTHER RISK FACTORS.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 18473030 ↗
• InjuryAug 14, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, HYDROCELE, MASS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Inflammation; Nodule; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17543225 ↗
• InjuryJun 19, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL HARM, DISCOMFORT, FAILURE OF MESH, DEFECTIVE MESH, ADHESIONS, RECURRENCE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, HERNIA REPAIR WITH NEW MESH AND TAKE DOWN OF ADHESIONS.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17156773 ↗
• InjuryMar 9, 2022Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, PAIN, TESTICULAR DISCOMFORT, ADHESIONS, MESH INGROWTH INTO WALL, INFLAMMATION, LEFT VARICOCELE, LOW SPERM COUNT, MALE PATTERN INFERTILITY, SCARRING, AND MENTAL ANGUISH. POST-OPERATIVE PATIENT TREATMENT INCLUDED PHYSICAL THERAPY, ANTI-INFLAMMATORY MEDICATION, MARCAINE AND DEXAMETHASONE INJECTIONS, DIAGNOSTIC BLOCK BY INJECTING BUPIVACAINE, EXCISION OF MESH, HERNIA REPAIR, ADHESIOLYSIS, SPERMATIC CORDS FREED, MRI, AND NEUROLYSIS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Erosion; Hernia; Inflammation; Pain; Perforation; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 13711161 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE AND HYDROCELE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ORCHIECTOMY AND REVISION SURGERY.

  Patient problems: Adhesion(s); Hernia; Injury; Ischemia; Nerve Damage; No Code Available; Pain; Scarring

  MAUDE report 10057505 ↗
• InjuryFeb 4, 2020Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, CHRONIC PAIN, RECURRENCE, INFLAMMATION, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, SCARRING, AND SWELLING ABDOMEN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Emotional Changes; Hernia; Inflammation; Injury; Pain; Scar Tissue; Swelling; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9666963 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION/REMOVAL AND REMOVAL OF CORD LIPOMA.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9606590 ↗
• MalfunctionJul 8, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A ROBOTIC ASSISTED INGUINAL HERNIA REPAIR, THE MESH WAS TORN/SHREDDED IT WAS PULLED THROUGH THE TROCAR. THEY GOT ANOTHER PRODUCT AND THE CASE WAS COMPLETED AS PLANNED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 8767912 ↗