CONMED GOLDLINE 131307ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30653405056632), received between Nov 10, 2016 and Feb 26, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR REPORTED THAT THE 131307A 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: THE DEVICE WAS RETURNED AND EVALUATED. THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT HAS BEEN REASSESSED AND MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469644 ↗
• MalfunctionFeb 18, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 131307A, 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 13558177 ↗
• MalfunctionJan 10, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 131307A, 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 13205273 ↗
• MalfunctionAug 26, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE,131307A, 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 12370407 ↗
• MalfunctionMar 17, 2017Unsealed Device Packaging; Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(6). REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, ONE (1) PACKAGE CONTAINING AN ULTRA CLEAN PENCIL 131307A WAS DISCOVERED WITH "INSUFFICIENT HEAT SEAL." IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: Not Applicable

  MAUDE report 6414442 ↗
• MalfunctionNov 10, 2016Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, 5 PACKAGES CONTAINING GOLDLINE ROCKER, HOLSTER, AND ULTRACLEAN WAS DISCOVERED WITH "INSUFFICIENT HEAT SEAL." THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER. THESE DEVICES WERE MANUFACTURED 18-MAY-2016. OF THE LOT CONTAINING (B)(4) UNITS, THERE WERE NO OTHER SIMILAR COMPLAINTS RECEIVED FOR THIS ITEM AND LOT NUMBER COMBINATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT HAS VERIFIED THAT THE DEVICES WERE PRODUCED ACCORDING TO THEIR CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. ANY NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY AND EFFECTIVENESS WERE NOT IDENTIFIED DURING MANUFACTURE. A 2-YEAR REVIEW OF PRODUCT HISTORY FOR THIS DEVICE FAMILY REVEALED 6 COMPLAINTS INVOLVING 11 DEVICES FOR THIS SIMILAR OCCURRENCE "INSUFFICIENT HEAT SEAL." DURING THIS SAME 2-YEAR TIME FRAME, OVER (B)(4) UNITS WERE SOLD WORLDWIDE, MAKING THE OCCURRENCE RATE FOR THIS FAILURE (B)(4) PERCENT. AS OF THIS FILING, THE DEVICE HAS NOT BEEN RECEIV

  Patient problems: No Patient Involvement; Not Applicable

  MAUDE report 6093634 ↗