Halyard 35212Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651352122), received between Aug 31, 2017 and Sep 11, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 16, 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.

• MalfunctionSep 11, 2017Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED 08-SEP-2017 THAT STATES, THE CUSTOMER REPORTED THE INCIDENT EVENT DATE IS (B)(6) 2017 FOR USER FACILITY REPORT # (B)(4). NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6854701 ↗
• MalfunctionAug 31, 2017Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED 08-SEP-2017 FROM THE CUSTOMER THAT STATES,THE INCIDENT EVENT DATE FOR (B)(4) IS (B)(6) 2017. ADDITIONAL INFORMATION WAS RECEIVED ON 11-SEP-2017 FROM THE CUSTOMER THAT STATES, "I SENT A REQUEST TO THE FDA TO AMEND THE DATE OF EVENT TO (B)(6) 2017 ON REPORT NUMBER (B)(4)." THE CUSTOMER DOES NOT KNOW HOW LONG THE PRODUCT WAS IN USE AND THE RESPONSE WAS "UNKNOWN." THE CUSTOMER ALSO REPORTED "UNKNOWN" AND DID NOT KNOW IF THE PATIENT'S OXYGEN SATURATION STABILIZED WITH THE TUBE CHANGE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Hypoxia; Low Oxygen Saturation

  MAUDE report 6837200 ↗