Halyard 13532Recalls & reported problems
Avanos Medical, Inc. · HALYARD* ON-Q* Catheters-Soaker* 2.5 In. (6.5cm) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651135329), received between Aug 22, 2017 and Aug 22, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2017Break; Break
FILL VOLUME: 750 ML, FLOW RATE: 3 ML/HR, PROCEDURE: POSTERIOR CERVICAL FUSION, CATHPLACE: INTRAMUSCULAR POSTERIOR CERVICAL SPINE. IT WAS REPORTED THAT THE PATIENT'S WIFE HAD CALLED ON (B)(6) 2017 AND NOTED THE PUMP TUBING BROKE FROM BASE OF THE PUMP CONNECTION. THE PATIENT'S WIFE CALLED THE HOSPITAL TO SEE WHAT NEEDED TO BE DONE, THE PATIENT SPOKE WITH A REGISTERED NURSE (RN). THE PATIENT TOLD THE NURSE SHE DISCONNECTED THE PUMP AT THE CATHETER CONNECTION. THE PATIENT'S WIFE WAS THEN DIRECTED TO REMOVE THE CATHETER FROM THE PATIENT. THE WIFE REMOVED THE CATHETER AFTER APPLYING A WARM COMPRESS ON THE CATHETER SITE. THE WIFE PULLED OUT THE CATHETER AND CLAIMED THE TIP WAS NOT VISIBLE AND STATED SHE THOUGHT THE CATHETER BROKE INSIDE THE PATIENT. THE WIFE WAS INSTRUCTED TO INFORM THE PATIENT'S DOCTOR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6810499 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.