Halyard 13701Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651137019), received between Dec 20, 2018 and Dec 20, 2018 — 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 16, 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.

• MalfunctionDec 20, 2018Break; Break

  FILL VOLUME: 100 ML, FLOW RATE: 2 ML/HR, PROCEDURE: BICEP TENDON REPAIR, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE PATIENT'S WIFE WAS REMOVING THE CATHETER, AND IT WAS COMING OUT SLOW AND STEADY WHEN SHE FELT A SNAP AT THE END. THERE WAS NO BLACK MARK AT THE END WHEN IT WAS PULLED OUT; IT LOOKED UNEVEN AND SNAPPED. THE PATIENT HAD NO OTHER COMPLAINTS. HE STATED IT DID NOT HURT AND HAD NO PAIN AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION RECEIVED ON 08-DEC-2018 STATED THAT THE PATIENT TALKED TO THE SURGEON WHO MENTIONED THAT IF HE (THE PATIENT) FELT COMFORTABLE, HE COULD WAIT UNTIL WEDNESDAY WHEN HIS APPOINTMENT WAS SCHEDULED. THE WIFE STATED THAT SHE WAS INSTRUCTED TO NOT REMOVE THE WHOLE SHOULDER BANDAGE, AND THAT SHE JUST LIFTED IT TO PULL THE CATHETER OUT. THE PATIENT WAS NOTED TO BE STABLE, IN PAIN FROM THE SURGERY BUT DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8184269 ↗

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