HysteroLux™ Hysteroscopic Inflow Tube Set 72205028Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056702005795), received between Nov 25, 2022 and Oct 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Missing Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K173489); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024

  COVIDIEN HYSTEROSCOPY TUBING FELL APART WHERE TUBING IS INSERTED INTO HYSTEROSCOPY MACHINE.

  Patient problems: Insufficient Information

  MAUDE report 20480612 ↗
• MalfunctionNov 25, 2022Missing Information; Missing Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: MFR REPORT # MW5112799: COVIDIEN HYSTEROLUX HYSTEROSCOPIC INFLOW TUBE SET- PACKAGING ARRIVED WITH NO LOT#, NO EXPIRATION DATE AND NO MANUFACTURE DATE LISTED. PRODUCT NOT USED AND RETURNED TO MANUFACTURER. ADDITIONAL INFORMATION PROVIDED BY THE DISTRIBUTOR: "08.11.2022 HS: FOR THIS ONE SINCE WE HAVE SUCH LIMITED INFORMATION, INCLUDING NO CONTACT INFORMATION, WE CANNOT SEND A REQUEST TO ANYONE ASKING FOR THE PRODUCT TO BE RETURNED. WE HAVE FILED IT UNDER (B)(4), PRODUCT:72205028, ITEM:10, LOT NO:UNKNOWN. FOR NOW, AFTER TALKING TO OUR PEOPLE, WE CAN CLOSE IT AS A NO SAMPLE AS WE ARE NOT EXPECTING TO GET THE PRODUCT BACK AT THIS TIME. IN THE OFF CHANCE THAT WE DO GET PRODUCT RETURNED THAT IS SOMEHOW TIED TO THE MEDWATCH OR THE PE WE CAN REOPEN THE COMPLAINT AND AMEND THE FILE AT THAT TIME. I HAVE CLOSED IT AS A NO SAMPLE TODAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15864221 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173489. One submission often covers many models, so check the product and lot details in each record.

• Z-2561-2021 · Jun 18, 2021 · Open, Classified
  Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000