CONMED 0036290Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10653405000471), received between Apr 20, 2016 and Mar 17, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  UPDATE 19FEB25: 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 THE DISTRIBUTOR REPORTED THAT THE 0036290 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617293 ↗
• MalfunctionNov 7, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, CATALOG # 0036290, LOT 202003104, FOR A POSSIBLE BREACH OF STERILITY DUE TO AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH ANY PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN (B)(6). THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. DUE TO THE BREACH IN STERILITY, THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758902 ↗
• MalfunctionAug 30, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0036290, 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 12385710 ↗
• MalfunctionMar 30, 2017Unsealed Device Packaging; Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, ONE (1) PACKAGE CONTAINING 1/4" X 10' SUCTION TUBING 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. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: Not Applicable

  MAUDE report 6446205 ↗
• MalfunctionMar 29, 2017Unsealed Device Packaging; Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, TWO (2) PACKAGES CONTAINING 1/4" X 10' SUCTION TUBING WERE 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. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: Not Applicable

  MAUDE report 6443609 ↗
• 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 1/4" X 10' SUCTION CONNECTION TUBING 0036290 WAS DISCOVERED WITH "DAMAGE WITH INSUFFICIENT HEATSEAL." 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 6415004 ↗
• MalfunctionJun 28, 2016Device Packaging Compromised

  THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, ONE (1) PACKAGE CONTAINING 1/4" X 10' SUCTION TUBING WAS DISCOVERED WITH "INSUFFICIENT HEAT SEAL". THE RETURNED PACKAGE EXHIBITED PARTIAL SEAL DISRUPTION IN THE FINAL MANUFACTURING SEALS. 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: No Patient Involvement

  MAUDE report 5756077 ↗
• MalfunctionMay 25, 2016Device Packaging Compromised

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, FOUR (4) PACKAGES CONTAINING 1/4" X 10' SUCTION TUBING WERE DISCOVERED WITH "INSUFFICIENT HEAT SEAL". ALL FOUR (4) OF THE RETURNED PACKAGES EXHIBITED PARTIAL SEAL DISRUPTION IN THE FINAL MANUFACTURING SEALS. 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: No Patient Involvement

  MAUDE report 5679565 ↗
• MalfunctionApr 20, 2016Tear, Rip or Hole in Device Packaging; Device Packaging Compromised

  THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, TWO (2) PACKAGES CONTAINING 1/4" X10' SUCTION TUBING WERE DISCOVERED WITH "INSUFFICIENT HEAT SEAL." ONE OF THESE RETURNED DEVICES EXHIBITED FULL OPEN SEAL DISRUPTION IN THE STERILE BARRIER 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: No Patient Involvement

  MAUDE report 5588007 ↗