GORE SEAMGUARD Bioabsorbable Staple Line Reinforce BSGEC60ACRecalls & reported problems
W. L. Gore & Associates, Inc. · BSGEC60 Anvil & Cartridge · Class 2 · Implant
All models of GORE SEAMGUARD Bioabsorbable Staple Line Reinforce (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132627004), received between Feb 1, 2024 and Feb 1, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Form Staple” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Form Staple1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Organ Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 1, 2024Fluid/Blood Leak; Failure to Form Staple; Fluid/Blood Leak; Failure to Form Staple
AT NUMEROUS TIMES THROUGHOUT 2023, THE PATIENT CALLED AND EMAILED GORE INQUIRING AS TO WHETHER GORE SHIPPED THE ETHICON STAPLER WITH ITS SEAMGUARD DEVICE. THE PATIENT REPORTED SHE HAS STOMACH CANCER AND STAPLES WERE COMING UNDONE AS A RESULT OF HER PHYSICIAN USING A RECALLED ETHICON STAPLER. VARIOUS GORE EMPLOYEES ADVISED THE PATIENT NUMEROUS TIMES THROUGHOUT 2023 THAT GORE DID NOT SELL OR SHIP THE ETHICON STAPLER. ON (B)(6), 2024 THE PATIENT FILED A LAWSUIT AGAINST GORE ALLEGING THE ECHELON FLEX ENDOPATH STAPLER RELOAD (BLACK, 60 MM X 4.4 MM, MODEL NO. ECR60T) AND THE GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT, PRODUCT 12BSGEC60 WERE DEFECTIVE PRODUCTS USED IN THE GASTRIC SLEEVE SURGERY PERFORMED ON (B)(6), 2016. REPORTEDLY, THE PATIENT ALLEGES THESE PRODUCTS CAUSED THE INCOMPLETE STAPLE LINE FORMATION RESULTING IN GASTRIC LEAK COMPLICATIONS. THE PATIENT REPORTED SHE HAS UNDERGONE CONTINUOUS TREATMENT FOR HER INJURIES CAUSED BY THE DEFECTIVE PRODUCTS AND RESULTING GASTRIC LEAK, INCLUDING, BUT NOT LIMITED TO, REMOVAL OF HER SPLEEN, REMOVED OF HER LEFT LOWER LUNG LOBE, AN ESOPHAGOSCOPY, GASTROSCOPY, DUODENOSCOPY FOR A PLEURAL FISTULA, REPAIR OF S DIAPHRAGMATIC HERNIA,
Patient problems: No Clinical Signs, Symptoms or Conditions; Organ Dehiscence
MAUDE report 18620629 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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