Halyard 13718Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651137187), received between Jun 13, 2017 and Aug 20, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2018Break; Break

  FILL VOLUME: UNKNOWN FLOW RATE: UNKNOWN PROCEDURE: SURGICAL PROCEDURE: VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) CATHPLACE: UNKNOWN A MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY DIRECTLY VIA MAIL, STATING "DURING REMOVAL OF PAIN BUSTER BALL, ONE OF THE WIRES BROKE OFF AND REMAINED IN PATIENT." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7798940 ↗
• MalfunctionJun 13, 2017Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: TUMMY TUCK, CATHPLACE: ABDOMEN. A REPORT WAS RECEIVED STATING THERE WAS A CATHETER BREAK. THE PATIENT PULLED CATHETER AND BROKE IT. ADDITIONAL INFORMATION RECEIVED 16-MAY-2017 STATED THE PATIENT HAS ABOUT 2 INCHES OF THE SILVER SOAKER CATHETER LEFT INSIDE THE PATIENT'S BODY. IT WAS DECIDED BY THE CLINICIANS TO NOT DO ANYTHING FURTHER REGARDING THIS CATHETER REMNANT. TWO CATHETERS WERE PLACED IN THE ABDOMEN OF THE PATIENT, WHO KNEW HOW TO REMOVE THE CATHETER AS SHE IS A NURSE. PATIENT REMOVED HER RIGHT-SIDE CATHETER UNEVENTFULLY. SHE THEN PROCEEDED TO REMOVE THE LEFT-SIDE CATHETER. INITIALLY, THE CATHETER WAS COMING OUT AS IT SHOULD UNTIL A LITTLE RESISTANCE WAS MET, "LIKE IT WAS CAUGHT ON SOMETHING". THE PATIENT REPOSITIONED HERSELF, THEN A LITTLE MORE OF THE CATHETER CAME OUT UNTIL IT FELT CAUGHT AGAIN. SHE AGAIN REPOSITIONED HERSELF, BUT THE CATHETER DID NOT COME OUT. AT THIS POINT, THE PATIENT DECIDED TO LAY DOWN AND ASKED HER HUSBAND TO REMOVE THE REST OF THE CATHETER FOR HER. A LITTLE MORE OF THE CATHETER CAME OUT, THEN IT BROKE. THERE WAS A SHORT PORTION OF STRETCHING NOTICED AT THE REMOVED END OF THE CATHETER. THE PATIENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6637324 ↗

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