Halyard 13471Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651134711), received between Jun 21, 2017 and Jun 21, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (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.

• MalfunctionJun 21, 2017Mechanical Jam; Mechanical Jam

  FILL VOLUME: 400 ML. FLOW RATE: UNKNOWN. PROCEDURE: R ANKLE TENDON REPAIR. CATHPLACE: UNKNOWN. IT WAS REPORT THAT A PATIENT EXPERIENCED AN ON DEMAND BOLUS BUTTON THAT WAS ABLE TO BE PRESSED DOWN, BUT CAME RIGHT BACK UP. THE ORANGE INDICATOR ALSO REMAINED AT THE BOTTOM. THE PATIENT DID NOT EXPERIENCE ANY SIDE EFFECTS. HOWEVER, THE PUMP WAS CLAMPED IMMEDIATELY, AND THE PATIENT'S WIFE WAS INSTRUCTED TO CONTACT THEIR ANESTHESIOLOGIST FOR FURTHER INSTRUCTIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6657827 ↗

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