Halyard 13627Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651136272), received between May 28, 2020 and May 28, 2020 — 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 18, 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.

• MalfunctionMay 28, 2020Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: C-SECTION, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT "WHEN THE CUSTOMER REMOVED THE CATHETER FROM A PATIENT, THE CATHETER WAS CUT AND A PART OF CATHETER WAS REMAINED IN BODY. SO THEY TOOK AN X-RAY TO FIND THE PART BUT THEY COULDN¿T SEE IT IN X-RAY." ADDITIONAL REPORT STATED "A SILVER SOAKER CATHETER BROKE WHEN IT WAS BEING REMOVED FROM A PATIENT. THE HEALTHCARE PROFESSIONAL WAS NOT ABLE TO LOCATE THE REMAINING PART VIA AN X-RAY." ADDITIONAL INFORMATION RECEIVED 12-MAY-2020 INDICATED "IN THE PROCESS OF REMOVING THE CATHETER, AFTER C-SECTION, SMALL PORTION OF THE CATHETER LEFT IN PATIENT. SO, HOSPITAL TOOK X-RAY TO FIND CATHETER, BUT CATHETER IS TOO SMALL TO FIND. IN THIS ISSUE, DOCTOR KEEP MONITORING PATIENT'S CONDITION. THERE IS NO PROBLEM WITH THE PATIENT'S CONDITION NOW." THE CATHETER WAS INSERTED THROUGH A STEEL NEEDLE AND WAS CONNECTED TO AN ON-Q ONDEMAND INFUSION PUMP.

  Patient problems: Foreign Body In Patient

  MAUDE report 10097247 ↗

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