Halyard 44935Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651449358), received between Aug 15, 2017 and Aug 15, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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 15, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN, FLOW RATE: 4 ML/HR, PROCEDURE: LUMBAR FUSION, CATHPLACE: JUST ABOVE LOWER BACK. IT WAS REPORTED THAT A PATIENT BEGAN TO EXPERIENCED SYMPTOMS OF DIZZINESS, BLURRED VISION, VOMITING AND HEADACHE IN THE LAST 3 HOURS. THE PATIENT DENIED THE SYMPTOM OF METALLIC TASTE. THE PATIENT HAD A 400 ML 4 ML/HR DUAL PUMP 2+2 AND ONLY ONE CATHETER INSERTED. THE OTHER WAS CLAMPED AND NOT INSERTED INTO THE SKIN. THE PATIENT WAS INSTRUCTED TO CLOSE THE CLAMPS ON THE TUBING AND TO CALL AN ANESTHESIOLOGIST. THE PATIENT'S PAIN WAS AN 8 OUT 10. ADDITIONAL INFORMATION RECEIVED ON 24-JUL-2017 STATED THAT THE PATIENT WAS DOING MUCH BETTER AND WAS IN STABLE CONDITION. THE SYMPTOMS DISSIPATED ONCE THE PUMP WAS DISCONTINUED AND THE CATHETER REMOVED ON (B)(6) 2017. THE PUMP WAS NOTED TO HAVE RUN SINCE (B)(6) 2017 AND NO SYMPTOMS WERE REPORTED BY THE PATIENT UNTIL (B)(6) 2017. THE SYMPTOMS WERE AT THEIR WORST ON (B)(6)2017 WHEN THE PATIENT EXPERIENCED HEADACHE AND BLURRY VISION. WHEN THE PUMP WAS REMOVED, IT WAS ALMOST EMPTY, BUT THE FILL VOLUME WAS NOT RECALLED. THE CATHETER WAS LOCATED JUST ABOVE THE LOWER BACK WITH AND CLEAN DRY, AND INTACT INSERTION SITE. NO WARMING DEVICES WERE USE. NO

  Patient problems: Blurred Vision; Dizziness; Headache; Vomiting

  MAUDE report 6795213 ↗

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