Halyard 44949Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651449495), received between Jul 13, 2017 and Dec 14, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2018Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: ABDOMINOPLASTY, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT A DOCTOR EXPERIENCED A CATHETER BREAK INCIDENT AFTER SHE PULLED IT OUT POST-OP DAY 3 AFTER AN ABDOMINOPLASTY PROCEDURE. THE CATHETER WAS SEVERED AT THE 20 CM GRADUATED MARK. WHEN IT WAS PULLED, IT CAME OUT WITH NO RESISTANCE. ADDITIONAL INFORMATION RECEIVED ON 03-DEC-2018 STATED THAT THE DOCTOR USUALLY SUTURES THE CATHETER TO THE SKIN TO KEEP IT FROM MOVING. UPON VISUAL INSPECTION OF THE CATHETER, IT DID APPEAR TO BE STRETCHED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8163831 ↗
• MalfunctionJun 25, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POSSIBLE CATHETER BREAK. ADDITIONAL INFORMATION RECEIVED STATED THAT WHEN REMOVING A PATIENT'S PAIN PUMP, IT FELT A LITTLE TIGHTER REMOVING THE LEFT SIDE. WHEN IT WAS PULLED OUT, THE TIP WAS NOT BLACK AND IT WAS CLEAR THAT A SUBSTANTIAL PIECE BROKE OFF AND WAS RETAINED IN THE PATIENT UNDER HER SKIN. IT WAS NOTED THAT IT WAS UNKNOWN IF THE TUBING WAS DEFECTIVE, BUT THE RETAINED PORTION WILL HAVE TO BE SURGICALLY REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7634168 ↗
• MalfunctionJul 13, 2017Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: C-SECTION, CATHPLACE: LOWER ABDOMEN. A REPORT WAS RECEIVED STATING THE CATHETER BROKE DURING USE. THE REGISTERED NURSE TRIED AGAIN TO REMOVE AND THE CATHETER BROKE OFF INSIDE THE PATIENT. PRIOR TO THE CATHETER REMOVAL THE NURSE TRIED WARM COMPRESSES THEN LAID THE PATIENT ON RIGHT AND LEFT SIDES. THE PATIENT STOOD UP AND SHE SAID IT WAS DIFFICULT WITH EACH PULL. THE CLINICIANS WERE SCARED TO BE PULLING AS HARD AS THEY WERE BUT THEY DEFINITELY WERE NOT LEANING BACK AND TUGGING DURING REMOVAL. IT IS ESTIMATED THAT APPROXIMATELY 3CM TO 4CM OF THE CATHETER WAS RETAINED IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6710461 ↗

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