ProGrip LPG1309ALRecalls & reported problems
Sofradim Production · Laparoscopic Self-Fixating Mesh, Left Anatomical · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521513204), received between Jun 15, 2018 and Feb 7, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).
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
Device problems
- Loss of or Failure to Bond1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
- Torn Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2022Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A TRANSABDOMINAL PREPERITONEAL PROCEDURE, AFTER OPENING THE PACKAGE, BEFORE USE ON THE PATIENT, PART OF THE LEFT END OF THE COLLAGEN FILM WAS BENT. THERE WAS DAMAGE ON THE LOWER LEFT PART OF THE ARROW. THE DEVICE WAS USED AS IT WAS AND DID NOT SEEM TO HAVE ANY PROBLEMS, HOWEVER, DUE TO THE CIRCUMSTANCE THAT IT WAS AFTER THE FACT, THE USER DECIDED TO KEEP IT REMAINED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13475545 ↗MalfunctionDec 26, 2019Loss of or Failure to Bond; Loss of or Failure to Bond
ACCORDING TO THE REPORTER, DURING A TRANSABDOMINAL PREPERITONEAL INGUINAL HERNIA REPAIR, THE DEPLOYED MESH CAME OFF WITHOUT RESISTANCE FROM THE GRIP AND WAS DISPLACED EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9519576 ↗MalfunctionJun 15, 2018Torn Material; Torn Material
ACCORDING TO THE REPORTER, WHEN DEPLOYING THE MESH WITH FORCEPS DURING A TOTALLY EXTRAPERITONEAL PROCEDURE, THE JOINT PART OF THE GREEN BAND TORE. THE DOCTOR LET THE DEVICE REMAIN IN CAVITY BECAUSE OF THE IT'S SPECIFICATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7606799 ↗
Other Mesh, surgical, polymeric devices
- PROCEED PVPMJohnson & Johnson International Inc. · Mesh, surgical, polymeric1,233 reports
- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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