2018-02-07 20:46:16 UTC

Voluntary Recall of Pentax ED-3490TK Duodenoscopes

Feb. 8, 2018

Recall designed to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap.

Pentax has issued a voluntary recall of all model ED-3490TK duodenoscopes in order to replace the forceps elevator mechanism, O-ring seal and distal end cap, and to update the Operation Manual to recommend annual maintenance. The design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap.

FDA cleared the updated design and labeling for the ED-3490TK on Feb. 7, 2018. For more information, review the full FDA Safety Communication on this issue.

AGA recommends all physicians closely follow FDA recommendations to eliminate the risk of device-associated infections. Regarding this new Pentax recall, FDA recommends health care facilities:

  • Acknowledge Pentax's Urgent Medical Device Correction and Removal notification disclaimer icon and identify affected products in use.
  • Return the field correction response form.
    • Indicate if you do NOT have any affected duodenoscopes or Operation Manuals. 
    • Upon receipt of the new Operation Manuals, remove and dispose of any older operation manuals in your facility.
  • Be aware of the manual reprocessing procedures outlined in FDA's Jan. 17, 2017, Safety Communication "UPDATE: Importance of Following Validated Reprocessing Instructions for Pentax-ED-3490TK Video Duodenoscopes."
    • Continue to use these validated instructions when reprocessing Pentax ED-3490TK duodenoscope models. The validated reprocessing instructions, when followed correctly, are intended to effectively clean and high-level disinfect the Pentax ED-3490TK duodenoscope.

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