Halyard 44937Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651449372), received between Aug 3, 2017 and Aug 3, 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. 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 3, 2017Break; Break

  FILL VOLUME: UNKNOWN FLOW RATE: UNKNOWN PROCEDURE: HEMORRHOIDECTOMY CATHPLACE: INCISIONAL IT WAS REPORTED THE PATIENT BROUGHT IN THE ON-Q PUMP AFTER REMOVAL. THE PATIENT NOTICED THAT ONE LIMB CAME OUT EARLY. WHEN THE PATIENT PULLED OUT THE OTHER SIDE OF THE DEVICE IT WAS NOTED THAT THERE WAS A DISCREPANCY IN LENGTH. THE PHYSICIAN STATED, "HE HAS NO SIGNS OF ABSCESS AT THE SITE. HE IS ONLY 3 WEEKS STATUS POST [S/P] HEMORRHOIDECTOMY, SO I'M NOT GOING TO GET TOO AGGRESSIVE NOW." THE PHYSICIAN DECIDED NOT TO PERFORM AN X-RAY OR PROCEDURE. THE INCISIONAL CATHETER MIGHT BE STILL INSIDE OF THE PATIENT BUT THERE IS NO REPORTED ADVERSE EVENT. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6764628 ↗

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