Halyard 13620Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651136203), received between Oct 23, 2017 and Oct 23, 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. 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.

• MalfunctionOct 23, 2017Break; Break

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: TOTAL ABDOMINAL HYSTERECTOMY. CATHPLACE: ABDOMINAL REGION. IT WAS REPORTED THAT A PATIENT EXPERIENCED A CATHETER BREAK DURING REMOVAL WITH 30-40 CM RETAINED IN THE PATIENT. THE USER WAS AN EXPERIENCED INTENSIVE CARE UNIT TRAINED NURSE AND HAS USED THE PRODUCT FOR YEARS. THE PATIENT HAD TO GO BACK FOR ANOTHER SURGERY TO REMOVE THE CATHETER. THE PATIENT IS REPORTED TO BE DOING FINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 6969959 ↗

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