GORE SEAMGUARD Bioabsorbable Staple Line Reinforce BSGEC60AACRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132627011), received between Jan 31, 2024 and Feb 1, 2024 — classified as 3 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, DR. EICHLER HAS EXPERIENCED THREE PROCEDURES RECENTLY WHERE THERE WAS INFECTION AND ABSCESS AT THE STAPLE LINE. THIS IS A COMPLICATION HE DOESN¿T TYPICALLY SEE WITH SUCH FREQUENCY. THIS HAS LED HIM TO INVESTIGATE POTENTIAL SOURCES OF CONTAMINATION, AND/OR RULE OUT CONTRIBUTING FACTORS. THE PROCEDURES WERE ALL DUODENAL SWITCHES AND GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT WAS USED ON THE DUODENAL TRANSECTION. ADDITIONAL PRODUCTS USED IN THE PROCEDURE INCLUDE AN ETHICON STAPLER, AND BAXTER PERI-STRIPS STAPLE LINE REINFORCEMENT ON THE GASTRIC POUCH. IT WAS REPORTED THERE WAS A RE-OPERATION AND NO PRE-EXISTING INFECTION IN THE LOCATION OF THE DEVICE OR SURROUNDING ADJACENT TISSUES. REPORTEDLY, THE COLOR CARTRIDGE BEING USED WAS WHITE AND THE INFECTION DID OCCUR AT THE ANASTOMOSIS. IT WAS REPORTED THE INFECTION WAS TREATED WITH REOPERATION (WASHOUT).

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 18620601 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, DR. (B)(6) HAS EXPERIENCED THREE PROCEDURES RECENTLY WHERE THERE WAS INFECTION AND ABSCESS AT THE STAPLE LINE. THIS IS A COMPLICATION HE DOESN'T TYPICALLY SEE WITH SUCH FREQUENCY. THIS HAS LED HIM TO INVESTIGATE POTENTIAL SOURCES OF CONTAMINATION, AND/OR RULE OUT CONTRIBUTING FACTORS. THE PROCEDURES WERE ALL DUODENAL SWITCHES AND GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT WAS USED ON THE DUODENAL TRANSECTION. ADDITIONAL PRODUCTS USED IN THE PROCEDURE INCLUDE AN ETHICON STAPLER, AND BAXTER PERI-STRIPS STAPLE LINE REINFORCEMENT ON THE GASTRIC POUCH. IT WAS REPORTED THERE WAS A RE-OPERATION AND NO PRE-EXISTING INFECTION IN THE LOCATION OF THE DEVICE OR SURROUNDING ADJACENT TISSUES. REPORTEDLY, THE COLOR CARTRIDGE BEING USED WAS WHITE AND THE INFECTION DID OCCUR AT THE ANASTOMOSIS. IT WAS REPORTED THE INFECTION WAS TREATED WITH A REOPERATION AND ANTIBIOTICS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 18619012 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, DR. (B)(6) HAS EXPERIENCED THREE PROCEDURES RECENTLY WHERE THERE WAS INFECTION AND ABSCESS AT THE STAPLE LINE. THIS IS A COMPLICATION HE DOESN¿T TYPICALLY SEE WITH SUCH FREQUENCY. THIS HAS LED HIM TO INVESTIGATE POTENTIAL SOURCES OF CONTAMINATION, AND/OR RULE OUT CONTRIBUTING FACTORS. THE PROCEDURES WERE ALL DUODENAL SWITCHES AND GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT WAS USED ON THE DUODENAL TRANSECTION. ADDITIONAL PRODUCTS USED IN THE PROCEDURE INCLUDE AN ETHICON STAPLER, AND BAXTER PERI-STRIPS STAPLE LINE REINFORCEMENT ON THE GASTRIC POUCH. IT WAS REPORTED THERE WERE RE-OPERATIONS AND NO PRE-EXISTING INFECTION IN THE LOCATION OF THE DEVICE OR SURROUNDING ADJACENT TISSUES. REPORTEDLY, THE COLOR CARTRIDGE BEING USED WAS WHITE AND THE INFECTION DID OCCUR AT THE ANASTOMOSIS. IT WAS REPORTED THE INFECTION WAS TREATED WITH ANTIBIOTICS, A REOPERATION AND AN EGD.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 18618920 ↗