Halyard 13533Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651135336), received between Dec 20, 2016 and May 21, 2019 — classified as 1 injury, 3 malfunctions.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2019Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS "FOUND BROKEN WHILE PATIENT WAS IN BED ¿ NOT WHEN ATTEMPTING TO REMOVE THE CATHETER. THE CATHETER WAS A MATTHEW¿S PLACEMENT BY THE ORTHOPEDIC SURGEON ON MONDAY, (B)(6) 2019 AND THERAPY WAS TO LAST UNTIL APPROXIMATELY THURSDAY. REMAINDER OF CATHETER REMOVED WITHOUT HARM TO PATIENT. NOTHING RETAINED IN THE PATIENT". ADDITIONAL INFORMATION RECEIVED THE SAME DAY INDICATED "POST OP [POST-OPERATIVE] DAY ONE BILATERAL TOTAL KNEE [THE SURGEON'S] PATIENT ON THE FLOOR 24 HOUR POSTOP REMAINDER OF CATHETER FULLY REMOVED FROM PATIENT. NOTHING LEFT INSIDE THE PATIENT. FOUND BROKEN, NOT DURING ANY ATTEMPT TO REMOVE CATHETER FROM PATIENT. THE PATIENT STILL HAS THE CATHETER AND PUMP WITH HIS OTHER KNEE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628896 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 700 ML, FLOW RATE: 1 TO 3 ML/HR, PROCEDURE: PEDIATRIC VATS PERFORMED ON (B)(6) 2018, CATHPLACE: TOP OF THE RIBS. IT WAS REPORTED THE PATIENT EXPERIENCED SUSTAINED AXILLARY NERVE APRAXIA AFTER THE USE OF THE CATHETER. THE DOCTORS WERE NOT SURE IF THE USE OF THE PUMP AND CATHETER CONTRIBUTED TO THE SYMPTOMS. THE PATIENT WAS NOT SURE WHEN THE SYMPTOMS STARTED DURING THE INFUSION PROCESS. THE DEVICE WAS REMOVED ON (B)(6) 2018. THE NEUROLOGY TEAM WAS CONSULTED AND PHYSICAL THERAPY (PT) WAS INITIATED PRIOR TO TRANSFER OF THE PATIENT. NO ADDITIONAL INFORMATION.

  Patient problems: No Code Available

  MAUDE report 7494637 ↗
• MalfunctionNov 15, 2017Break; Break

  PROCEDURE: KNEE REPLACEMENT. CATHPLACE: BOTH WERE NEAR KNEE, SURGICAL SITES. IT WAS REPORTED THAT A PATIENT HAD DUAL CATHETERS, ONE OF WHICH CAME OUT DURING PATIENT USAGE. THE PATIENT CALLED THE SURGEON AND INSTRUCTED THE PATIENT TO REMOVE THE SECOND CATHETER. THE PATIENT KEPT PULLING AND MET RESISTANCE, AND IT BROKE. THE SURGEON ORDER AN X-RAY AND SAW A PORTION OF THE CATHETER RETAINED IN THE PATIENT. THE SURGEON DECIDED TO LEAVE THE PIECE INSIDE THE PATIENT FOR NOW.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7032744 ↗
• MalfunctionDec 20, 2016Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: ORTHOPEDIC SURGERY, CATHETER PLACE: UNKNOWN. IT WAS REPORTED THAT A PATIENT CATHETER BROKE OFF INSIDE THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6188432 ↗