CONMED 0036280Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10653405000464), received between Apr 20, 2016 and Sep 24, 2021 — 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.

• MalfunctionSep 24, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, CATALOG # 0036280, LOT 202006265, 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 JAPAN. 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 12528341 ↗
• MalfunctionSep 1, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0036280, 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 12408482 ↗
• MalfunctionAug 30, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, CATALOG # 0036280, LOT 202001145, 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 JAPAN. 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 12385543 ↗
• MalfunctionMar 28, 2017Device Packaging Compromised; Device Packaging Compromised

  AS REPORTED BY THE DISTRIBUTOR IN (B)(4), ONE (1) 1/4" X 6' SUCTION TUBING PACKAGE WAS DISCOVERED TO HAVE AN "INSUFFICIENT HEATSEAL." 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. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: Not Applicable

  MAUDE report 6440363 ↗
• MalfunctionMar 28, 2017Device Packaging Compromised; Device Packaging Compromised

  AS REPORTED BY THE DISTRIBUTOR IN (B)(6), THREE (3) 0036280 1/4" X 6' SUCTION TUBING PACKAGES WERE DISCOVERED TO HAVE AN "INSUFFICIENT HEATSEAL OR BLISTER PACK." 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. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: Not Applicable

  MAUDE report 6438466 ↗
• MalfunctionFeb 2, 2017Unsealed Device Packaging; Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, ONE (1) PACKAGE CONTAINING ONE (1) EACH 1/4" X 6' 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.

  Patient problems: Not Applicable

  MAUDE report 6299011 ↗
• MalfunctionJan 13, 2017Unsealed Device Packaging; Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, 2 PACKAGES CONTAINING 1/4" X 6' SUCTION TUBING WAS DISCOVERED WITH "DEFECTIVE SEAL." 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 6248860 ↗
• MalfunctionDec 20, 2016Unsealed Device Packaging; Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, TWO (2) PACKAGES CONTAINING ONE (1) EACH 1/4" X 6' 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.

  Patient problems: Not Applicable

  MAUDE report 6192087 ↗
• MalfunctionApr 20, 2016Device Packaging Compromised

  THE DISTRIBUTOR IN JAPAN REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, TWO (2) PACKAGES CONTAINING 1/4" X 6' SUCTION TUBING WERE DISCOVERED WITH "INSUFFICIENT HEAT SEAL". BOTH OF THE RETURNED PACKAGES EXHIBITED FULL OPEN 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 5587926 ↗