ProGrip LPG1614Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521513242), received between Nov 4, 2019 and Feb 8, 2024 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2024Difficult to Insert; Product Quality Problem; Difficult to Insert; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRA-PERITONEAL (TEP) UNILATERAL INGUINAL HERNIA PROCEDURE, WHEN THE SURGEON WAS UNFOLDING THE MESH TO PLACE AND FIXATE IT INTO THE TISSUE, THE SURGEON REALIZED IT WAS INCORRECTLY FOLDED. THE SURGEON EXTRACTED THE MESH OUT OF THE PATIENT THROUGH THE PORT, AND THE MESH GOT STUCK IN THE SEAL, AND THE SEAL DISLODGED. MOREOVER, THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE. IT WAS NOTED THAT THE MESH WAS ABLE TO BE PULLED OUT WITH THE SEAL ATTACHED TO IT. THE SURGEON REUSED THE SAME PORT WITHOUT THE SEAL, AND THE SURGICAL ASSISTANT USED THE CAMERA AND THEIR HAND WITH A SURGICAL PACK TO COVER THE SEAL AND TO STOP GAS FROM LEAKING. TO RESOLVE THE ISSUE, A NEW PORT WAS OPENED, BUT IT WAS NOT USED, AND USED A NEW PIECE OF MESH IN THE PATIENT IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667418 ↗
• MalfunctionJan 10, 2024Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL EXTRAPERITONEAL (TEP) LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE FIRST MESH WAS CUT, FOLDED, AND PLACED DOWN THE STRUCTURAL BALLOON PORT WITH NO ISSUE. THE NEXT MESH WAS CUT AND FOLDED THE SAME WAY, PLACED DOWN THE STRUCTURAL PORT, AND BECAME STUCK IN THE MIDDLE OF THE PORT. THE SURGEON FORCED IT DOWN, AND IT GOT CAUGHT IN THE SEAL AND TEARED IT OFF. THE SEAL OF THE STRUCTURAL BALLOON FELL INTO THE PATIENT'S CAVITY AND WAS ABLE TO BE RETRIEVED. A NEW STRUCTURAL BALLOON AND MESH WERE USED WITH THE SAME LOT FOR BOTH DEVICES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18488810 ↗
• MalfunctionAug 18, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT INGUINAL HERNIA REPAIR USING TOTALLY EXTRAPERITONEAL (TEP) TECHNIQUE, AFTER THE DISSECTION WAS COMPLETED AND THE MESH WAS READY TO BE PLACED, WHEN THE SURGEON TRIED TO PLACE THE MESH DOWN THE PORT AND THE VALVE SEAL DISENGAGED AND WAS PUSHED INTO THE PORT, IT BECOME STUCK INSIDE THE PORT WITH THE MESH AND WAS UNABLE TO BE PUSHED DOWN OR TAKEN OUT. THE SURGEON USED A NEW DEVICE AND A NEW PIECE OF MESH AND THE ISSUE DID NOT RE-OCCUR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17576977 ↗
• MalfunctionAug 15, 2023Loss of or Failure to Bond; Difficult to Insert; Loss of or Failure to Bond; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR (TEP), THE GREY SEAL, FELL INTO THE CAVITY OF THE PATIENT. THE GREY SEAL GOT DETACHED FROM THE PORT AND BECAME STUCK HALFWAY ALONG THE MESH. ADDITIONALLY, THE MESH HAD BECOME ADHERED TO MUSCLE AND OTHER TISSUES NEAR THE PORT TIP. TO RESOLVE THE ISSUE, THE FAULTY PORT WAS REMOVED, AND THE MESH HAD TO BE FORCEFULLY PULLED OUT THROUGH THE PORT INCISION. THE GREY SEAL WAS ALSO REMOVED FROM THE MESH. AS A RESULT OF THIS PROBLEM, THERE WAS TISSUE DAMAGE TO THE RECTUS ABDOMINIS MUSCLE AND OTHER TISSUES SURROUNDING THE PORT SITE. THE DAMAGE OCCURRED WHILE FORCIBLY REMOVING THE MESH FROM THE PORT SITE. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, ANOTHER TROCAR WAS OPENED. MOREOVER, THE DEVICE ISSUE CAUSED A RAPID LOSS OF ABDOMINAL PRESSURE.

  Patient problems: Tissue Breakdown

  MAUDE report 17553610 ↗
• MalfunctionAug 15, 2023Loss of or Failure to Bond; Difficult to Insert; Loss of or Failure to Bond; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) BILATERAL INGUINAL HERNIA REPAIR, AS THE SECOND PIECE OF MESH WAS BEING PASSED THROUGH THE PORT, THE GREY SEAL CAME COMPLETELY OFF. THE SURGEON ATTEMPTED TO REPAIR THE PORT, BUT THE SEAL WOULD NOT REMAIN IN PLACE AND INSUFFLATION GAS CONTINUED TO LEAK. DUE TO RAPID LOSS OF ABDOMINAL PRESSURE, THE MESH USED BECAME ATTACHED TO UNINTENDED TISSUE. PROCEDURE TIME WAS EXTENDED (BY LESS THAN 30 MINUTES), WHILE THE SURGEON REMOVED THE MESH FROM THESE TISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17551025 ↗
• MalfunctionAug 11, 2023Loss of or Failure to Bond; Difficult to Insert; Loss of or Failure to Bond; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) BILATERAL INGUINAL HERNIA REPAIR, AS THE SECOND PIECE OF MESH WAS BEING PASSED THROUGH THE PORT, THE GREY SEAL CAME COMPLETELY OFF. THE SURGEON ATTEMPTED TO REPAIR THE PORT, BUT THE SEAL WOULD NOT REMAIN IN PLACE AND INSUFFLATION GAS CONTINUED TO LEAK. DUE TO RAPID LOSS OF ABDOMINAL PRESSURE, THE MESH USED BECAME ATTACHED TO UNINTENDED TISSUE. PROCEDURE TIME WAS EXTENDED (BY LESS THAN 30 MINUTES), WHILE THE SURGEON REMOVED THE MESH FROM THESE TISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514075 ↗
• MalfunctionAug 7, 2023Loss of or Failure to Bond; Difficult to Insert; Loss of or Failure to Bond; Difficult to Insert

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, AS THE MESH WAS BEING INTRODUCED THROUGH THE TROCAR, THE VALVE SEAL COMPLETELY CAME OFF. THE TROCAR WAS ATTEMPTED TO BE FIXED. THE SURGEON TRIED RE-FITTING THE OUTER GREY SEAL. DUE TO RAPID AND CONTINUED LOSS OF ABDOMINAL PRESSURE, THE BALLOON WAS DEFLATED, REMOVED, AND THE DEVICE WAS REPLACED. THE MESH WHICH WAS BEING USED UNINTENDEDLY GOT STUCK TO THE TISSUE. THE LENGTH OF THE PROCEDURE INCREASED WHILE THE SURGEON DETACHED THE MESH FROM THIS UNINTENDED TISSUE. THE MESH WAS STILL ABLE TO BE USED, AND WAS SUCCESSFULLY IMPLANTED. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477126 ↗
• MalfunctionAug 1, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, AN ISSUE OCCURRED AS THE MESH WAS BEING INSERTED THROUGH THE TROCAR, CAUSING THE OUTER GREY SEAL TO COMPLETELY COME OFF. THE SURGEON MANAGED TO REATTACH THE GREY SEAL USING FORCEPS. HOWEVER, THE ABDOMINAL PRESSURE COULD NOT BE MAINTAINED. THE MESH USED BECAME ATTACHED TO UNINTENDED TISSUE DUE TO THE LACK OF ABDOMINAL PRESSURE. THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE RESULTED FROM THE DEVICE ISSUE. TO FULLY RESOLVE THE ISSUE, THE SURGEON NEEDED TO SPEND ADDITIONAL TIME REMOVING THE MESH FROM THIS UNINTENDED TISSUE, LEADING TO A MODERATE INCREASE IN THE PROCEDURE TIME, NOT EXCEEDING 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437972 ↗
• MalfunctionJul 31, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, AN ISSUE OCCURRED AS THE MESH WAS BEING INSERTED THROUGH THE TROCAR, CAUSING THE OUTER GREY SEAL TO COMPLETELY COME OFF. THE SURGEON MANAGED TO REATTACH THE GREY SEAL USING FORCEPS. HOWEVER, THE ABDOMINAL PRESSURE COULD NOT BE MAINTAINED. THE MESH USED BECAME ATTACHED TO UNINTENDED TISSUE DUE TO THE LACK OF ABDOMINAL PRESSURE. THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE RESULTED FROM THE DEVICE ISSUE. TO FULLY RESOLVE THE ISSUE, THE SURGEON NEEDED TO SPEND ADDITIONAL TIME REMOVING THE MESH FROM THIS UNINTENDED TISSUE, LEADING TO A MODERATE INCREASE IN THE PROCEDURE TIME, NOT EXCEEDING 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430445 ↗
• MalfunctionMay 10, 2023Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA, THE INSERTION OF MESH CAUSED THE VALVE TO COME UNSTUCK AND BE PUSHED DOWN THE TROCAR. NO COMPONENT FELL INTO THE CAVITY. THE SURGEON TRIED TO RETRIEVE VALVE TO CONTINUE, BUT NEEDED TO REPLACE ENTIRE STRUCTURAL BALLOON PORT AS USER WAS UNABLE TO CONTINUE DUE TO THE DISLODGED VALVE BLOCKING THE TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904498 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER FIXING THE HERNIA DEFECT IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, PATIENT WAS COMPLAINING ABOUT THE CHRONIC PAIN WHERE MESH WAS IMPLANTED. THE PATIENT IS BEEN SENT TO DO SCANNING TO LOCATE THE RIGHT REASON FOR PAIN IN INGUINAL AREA.

  Patient problems: Pain; Unintended Radiation Exposure

  MAUDE report 12316115 ↗
• InjuryNov 4, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST LAPAROSCOPIC BILATERAL INGUINAL REPAIR, THE PATIENT RETURNED FOR A ROBOTIC INGUINAL HERNIA REPAIR FOR REOCCURRENCE. THE MESH IMPLANTS WERE REMAIN INSTITUTE AND SHOW GOOD INTEGRATION EXCEPT FOR THE HOLE IN THE RIGHT SIDED MESH. HERNIA DEFECT REPAIR WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 9274639 ↗