Halyard 13723Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651137231), received between Aug 25, 2017 and Aug 25, 2017 — 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

Recent adverse event reports

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

• MalfunctionAug 25, 2017Break; Break

  FILL VOLUME: 550 ML, FLOW RATE: UNKNOWN, PROCEDURE: BARIATRIC SURGERY, CATHPLACE: BELOW BREAST BONE. IT WAS REPORTED A CATHETER BREAK OCCURRED. THE PATIENT REMOVED THE DUAL CATHETERS. ONE CATHETER CAME OUT WITHOUT ANY ISSUES. THE PATIENT DID NOT FEEL ANY RESISTANCE WHEN REMOVING THE SECOND CATHETER HOWEVER, THE PATIENT FELT IT SNAPPED OFF. THE PATIENT STATED THAT IT BROKE ABOVE THE SOAKING PORTION. THEREFORE, THE PATIENT CALLED HIS DOCTOR WHO INFORMED HIM TO GO TO THE EMERGENCY ROOM (ER). A SURGICAL RESIDENT AT THE ER ASSESSED THE PATIENT AND DETERMINED THE CATHETER DID INDEED BREAK. THE PATIENT WAS DOING WELL AND WAS IN STABLE IN CONDITION. THE PATIENT DID NOT EXHIBIT ANY SIGNS AND SYMPTOMS OF INFECTION. AN X-RAY WAS ALSO COMPLETED. THE HEALTHCARE PROVIDERS ARE PLANNING TO RETRIEVE THE CATHETER BY MAKING A SMALL INCISION AND REMOVING IT OUT. THE HEALTHCARE PROVIDERS PLANNED TO DO THIS IN THE ER. THE HEALTHCARE PROVIDERS DID NOT SUSPECT THAT THE CATHETER WAS DEEP INSIDE THE PATIENT AS IT BROKE NEAR THE CATHETER INSERTION SITE. IT WAS SUSPECTED THAT 10 CM OF THE CATHETER WAS LEFT AS THE CATHETER BROKE RIGHT ABOVE THE SOAKING SECTION. ADDITIONAL INFORMATION RECEIVED (B)(6) 2017 STATE

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6822975 ↗

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