Halyard 13656Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651136562), received between Mar 2, 2018 and Mar 2, 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2018Break; Break

  FILL VOLUME: N/A. FLOW RATE: N/A. PROCEDURE: UNKNOWN . CATHPLACE: WOUND BED. IT WAS REPORTED THAT A CATHETER BROKE INSIDE OF A PATIENT DURING REMOVAL, AND WAS REQUIRED TO GO BACK INTO SURGERY FOR REMOVAL. ADDITIONAL INFORMATION RECEIVED ON 19-FEB-2018 FROM (B)(6) ADVERSE INCIDENT REPORT (B)(6) STATED THAT THE DATE OF THE INCIDENT WAS (B)(6) 2018. IT WAS STATED THAT "SOAKER CATHETER LAYING IN WOUND BED SNAPPED DURING REMOVAL, LEAVING SIGNIFICANT PORTION INSIDE PATIENT." THE PATIENT WAS REQUIRED TO RETURN TO SURGERY HAVE AN RE-OPENING OF THE ORIGINAL SUTURE LINE IN ORDER TO REMOVE THE RETAINED SECTION OF BROKEN CATHETER UNDER GENERAL ANESTHESIA. THE PATIENT'S RETURN TO SURGERY WAS UNEVENTFUL AND PLANS FOR PATIENT DISCHARGE WAS NOT PUSHED BACK. IT WAS NOTED THAT THERE WERE NO INDICATION OF PROBLEMS DURING INITIAL CATHETER INSERTION, NOR DURING USE OR THE INITIAL STAGES OF REMOVAL. THE STAFF WAS STATED TO BE FAMILIAR WITH THE PRODUCT. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7310743 ↗

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