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Halyard 13649Recalls & reported problems

Avanos Medical, Inc. · ON-Q* Pain Relief System with Dual SOAKER* Catheters, 400 ml, 4 ml/hr (2+2 ml/hr), 5 in./12.5 cm · 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 10680651136494), received between Jul 19, 2018 and Jul 19, 2018 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K063530); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 19, 2018Break; Break

    PROCEDURE: UNKNOWN. CATHPLACE: PRE-PERITONEAL SPACE. IT WAS REPORTED A CATHETER BREAK OCCURRED. THE PHYSICIAN STATED THE SOAKER CATHETER BROKE AND WAS LEFT IN THE PATIENT'S BODY. ADDITIONAL INFORMATION RECEIVED 09-JUL-2018 STATED THE DOCTOR WAS UNABLE TO FIND THE REMAINDER OF THE CATHETER INSIDE THE PATIENT. ADDITIONAL INFORMATION RECEIVED 13-JUL-2018 STATED THE HOSPITAL WAS UNCERTAIN IF THE BROKEN CATHETER WAS INSIDE THE PATIENT. ADDITIONAL INFORMATION RECEIVED 15-JUL-2018 STATED THE SOAKER CATHETER WAS PLACED AT THE PRE-PERITONEAL SPACE AND WAS REMOVED BY THE PHYSICIAN. 'IT WAS BROKEN INSIDE OF THE PATIENT." THERE WAS NO REPORTED INJURY.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7703475 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063530. One submission often covers many models, so check the product and lot details in each record.

  • Z-2860-2011 · Apr 15, 2011 · Terminated
    I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for p
  • Z-2133-2008 · Feb 14, 2008 · Terminated
    On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narc
  • Z-1869-2008 · Feb 12, 2008 · Terminated
    ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anest

Other PUMP, INFUSION, ELASTOMERIC devices

All PUMP, INFUSION, ELASTOMERIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.