Halyard 13539Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10680651135398), received between Dec 20, 2016 and Apr 3, 2019 — classified as 2 deaths, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2019Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE ON-Q CATHETER BROKE IN-SITU DURING AN ATTEMPTED REMOVAL. THE PATIENT WAS TAKEN BACK TO SURGERY WHERE THE REMAINING PART OF THE CATHETER WAS REMOVED, APPROXIMATELY 27CM IN LENGTH. THERE WAS NO REPORTED COMPLICATIONS FROM THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8477172 ↗
• DeathJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED 16-APR-2018, AUTOPSY REPORT. FINDINGS: 1. SUDDEN CARDIAC ARREST FOLLOWING BUPIVACAINE ADMINISTRATION THROUGH CATHETER ROUTED INTO SUBCUTANEOUS ADIPOSE TISSUE WHILE UNDER SEDATION PRIOR TO COMMENCEMENT OF SURGICAL CORRECTION OF PECTUS EXCAVATUM. A. REFRACTORY TO EXTENSIVE CARDIOPULMONARY RESUSCITATION WHICH INCLUDED ADMINISTRATION OF INTRALIPID. B. CATHETER REMOVED BY MEDICAL PERSONNEL AFTER CARDIAC ARREST. C. BUPIVACAINE IN VIALS THAT ADMINISTERED DRUG WAS DRAWN FROM OF EXPECTED CONCENTRATION; SPECIMENS SUBMITTED DIRECTLY TO TOXICOLOGY LABORATORY FROM CHILDREN¿S MEDICAL CENTER AT LEGACY. 2. STRUCTURALLY NORMAL HEART EXAMINATION THAT INCLUDED CONDUCTION SYSTEM STUDY. CONCLUSION: I AM OF THE OPINION THAT (B)(6), A (B)(6) FEMALE, DIED AS A RESULT OF BUPIVACAINE CARDIAC TOXICITY. REASONS FOR THIS SUDDEN CARDIAC ARREST INCLUDE INTRAVASCULAR PLACEMENT OF THE CATHETER OR AN ADVERSE/IDIOSYNCRATIC DRUG REACTION. MANNER OF DEATH: ACCIDENT.

  Patient problems: Cardiac Arrest; Death; No Code Available; Reaction; Toxicity

  MAUDE report 7207731 ↗
• DeathJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED 16-APR-2018, AUTOPSY REPORT. FINDINGS: 1. SUDDEN CARDIAC ARREST FOLLOWING BUPIVACAINE ADMINISTRATION THROUGH CATHETER ROUTED INTO SUBCUTANEOUS ADIPOSE TISSUE WHILE UNDER SEDATION PRIOR TO COMMENCEMENT OF SURGICAL CORRECTION OF PECTUS EXCAVATUM. A. REFRACTORY TO EXTENSIVE CARDIOPULMONARY RESUSCITATION WHICH INCLUDED ADMINISTRATION OF INTRALIPID. B. CATHETER REMOVED BY MEDICAL PERSONNEL AFTER CARDIAC ARREST. C. BUPIVACAINE IN VIALS THAT ADMINISTERED DRUG WAS DRAWN FROM OF EXPECTED CONCENTRATION; SPECIMENS SUBMITTED DIRECTLY TO TOXICOLOGY LABORATORY FROM (B)(6) MEDICAL CENTER AT (B)(6). 2. STRUCTURALLY NORMAL HEART EXAMINATION THAT INCLUDED CONDUCTION SYSTEM STUDY. CONCLUSION: I AM OF THE OPINION THAT (B)(6), A (B)(6) FEMALE, DIED AS A RESULT OF BUPIVACAINE CARDIAC TOXICITY. REASONS FOR THIS SUDDEN CARDIAC ARREST INCLUDE INTRAVASCULAR PLACEMENT OF THE CATHETER OR AN ADVERSE/IDIOSYNCRATIC DRUG REACTION. MANNER OF DEATH: ACCIDENT.

  Patient problems: Cardiac Arrest; Death; No Code Available; Reaction; Toxicity

  MAUDE report 7207677 ↗
• MalfunctionFeb 7, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2017-00015 FOR THE FIRST PATIENT. REFER TO 2026095-2017-00017 FOR THE THIRD PATIENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: NUSS PROCEDURES. CATHPLACE: PATIENT'S BACK. IT WAS REPORTED THAT THREE PATIENTS HAD CATHETERS BROKEN CATHETERS LEFT INSIDE THEIR BACKS IN THE LAST THREE MONTHS. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6309612 ↗
• MalfunctionFeb 7, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2017-00016 FOR THE SECOND PATIENT. REFER TO 2026095-2017-00017 FOR THE THIRD PATIENT. PROCEDURE: NUSS PROCEDURES. CATHPLACE: PATIENT'S BACK. IT WAS REPORTED THAT THREE PATIENTS HAD CATHETERS BROKEN CATHETERS LEFT INSIDE THEIR BACKS IN THE LAST THREE MONTHS. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6309610 ↗
• MalfunctionFeb 7, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2017-00015 FOR THE FIRST PATIENT. REFER TO 2026095-2017-00016 FOR THE SECOND PATIENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: NUSS PROCEDURES. CATHPLACE: PATIENT'S BACK. IT WAS REPORTED THAT THREE PATIENTS HAD CATHETERS BROKEN CATHETERS LEFT INSIDE THEIR BACKS IN THE LAST THREE MONTHS. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6309609 ↗
• MalfunctionDec 20, 2016Break; Break

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHETER PLACE: UNKNOWN. IT WAS REPORTED THAT A PATIENT CATHETER BROKE INSIDE THE PATIENT. IT WAS DETERMINED THAT CATHETER REMNANT INSIDE THE PATIENT WOULD BE LEFT AS IT WAS SINCE THE RISK OF REMOVING IT WAS GREATER THAN THE BENEFIT FOR THIS PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6189697 ↗