CONMED GOLDLINE 131309ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30653405056274), received between Aug 29, 2019 and Sep 18, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (6 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 131309A, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082571 ↗
• MalfunctionAug 6, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 131309A, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726186 ↗
• MalfunctionFeb 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR REPORTED THAT THE 131309A DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. THE SHIPMENT ASSOCIATED WITH THE RGA FOR THIS DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION AND IT HAS NOT BEEN CONFIRMED THAT AN INSUFFICIENT HEATSEAL CAUSING A STERILITY BREACH HAS OCCURRED. BASED ON THE INFORMATION AVAILABLE, AND THE DECISION TREE RESULTS, THIS COMPLAINT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. UPON THE RECEIPT OF THE DEVICE, AN EVALUATION WILL BE CONDUCTED AND IF A BREACH OF STERILITY IS CONFIRMED THE REPORTING DECISION WILL BE REASSESSED AT THAT TIME. UPDATE: 19FEB2025 - THE DEVICE HAS BEEN RETURNED AND AN EVALUATION HAS BEEN COMPLETED. AN INSUFFICIENT HEATSEAL WAS DISCOVERED AFTER TESTING. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470557 ↗
• MalfunctionApr 17, 2024Self-Activation or Keying; Self-Activation or Keying

  A CUSTOMER REPORTED THAT THE 131309A, GOLDLINE, BTN, HOLST, ULTRACLEAN DEVICE WAS BEING USED DURING AN UNNAMED PROCEDURE ON (B)(6) 2024, AND THE DEVICE ¿STARTED GOING OFF BY ITS SELF¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE SAME DEVICE AND WITH NO DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19123786 ↗
• MalfunctionOct 7, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 131309A, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15560969 ↗
• MalfunctionOct 5, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 131309A, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543567 ↗
• MalfunctionNov 4, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, (B)(4), FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751421 ↗
• InjuryAug 29, 2019Arcing; Arcing

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 131309A DEVICE WAS BEING USED DURING A MASTOPEXY ON (B)(6) 2019. THE SURGEON STATED THAT BLOOD ACCUMULATED AT THE TIP WHICH COULD HAVE CAUSED AN ARCED/SPARK CAUSING HIS GLOVES TO POP. THE EVENT CAUSED A 5-MINUTE DELAY; HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE REPRESENTATIVE WAS LATER SHOWN BY THE SURGEON THAT HE HAD A BLISTER ON THE FIRST KNUCKLE OF THE SECOND DIGIT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE BURN OF UNKNOWN DEGREE.

  Patient problems: Burn(s)

  MAUDE report 8944156 ↗