Graftgun Universal Graft Delivery System - Cartridge Kit IG-K-1000Recalls & reported problems
Surgentec, LLC · Graftgun Universal Graft Delivery System - Cartridge Kit labeled with new catalog number for distribution by Integrity Implants · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858406007433), received between Feb 25, 2025 and Feb 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Problem with Sterilization” (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
- Problem with Sterilization1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2025Problem with Sterilization; Problem with Sterilization
REP SENT IN A USAGE SHEET WITH A CASE DATE ON (B)(6) 2025, WHICH INCLUDED THE GG-K-1000 WHICH HAD AN EXPIRATION DATE OF JANUARY 27TH, 2025. THE REP ALSO STATED THAT THIS WAS THE SIXTH CASE OF THE DAY SO WHEN SHE READ OUT THE EXPIRATION DATES, NO ONE NOTICED THAT THE EXPIRY DATE HAD PASSED. AT THE TIME OF SURGERY, IT DID NOT CAUSE ANY PATIENT HARM DURING THE CASE. THE PATIENT DID NOT STAY UNDER ANESTHESIA LONGER THAN INITIALLY REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21462077 ↗
Other Syringe, Piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page