Halyard 13623Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651136234), received between May 11, 2017 and Jan 3, 2019 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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 18, 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.

• DeathJan 3, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 420 ML. FLOW RATE: 4 ML/HR. PROCEDURE: RIGHT HEPATECTOMY PLUS CHOLECYSTECTOMY. CATHPLACE: PREPERITONEAL LEFT AND RIGHT ABDOMINAL. DATE TIME INFUSION STARTED: (B)(6) 2018 7:30 PM. DATE TIME INFUSION STOPPED: (B)(6) 2018 6:30 PM. IT WAS REPORTED THE PATIENT WAS USING AN ELASTOMERIC DEVICE. THE PATIENT PASSED AWAY FOLLOWING A HEPATECTOMY PROCEDURE ON POST OPERATIVE DAY (POD) 4. THE PATIENT HAD NOT RECEIVED ROPIVACAINE 0.2% IN THE PAST. THE PATIENT DID NOT EXHIBIT ANY DRUG RELATED SYMPTOMS OR SIDE EFFECTS. THE CLINICIANS ARE UNSURE IF THE EVENT WAS RELATED TO THE USE OF THE DEVICE AND UNSURE IF THERE WAS ANY ABSORPTION OF THE ROPIVACAINE INTO THE CIRCULATORY SYSTEM. THE ELASTOMERIC DEVICE WAS NOT EMPTY AT THE END OF INFUSION AND TIME OF DISCONNECTION. THE REPORTED ENVIRONMENTAL CONDITIONS OF THE DEVICE DURING USE WERE MODERATELY COOL, LOW HUMIDITY AND THE DEVICE WAS UNDER BLANKETS WHILE IN USE ON THE PATIENT. THE PATIENT EVENTUALLY DEVELOPED ARRHYTHMIAS. THE DEVICE WAS REMOVED POD 2, THE CLINICIANS WERE UNSURE REGARDING THE CAUSE OF THE PATIENT'S CARDIAC ARRHYTHMIAS IN RELATION TO THE ROPIVACAINE. ON (B)(6) 2018 ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT DEVEL

  Patient problems: Death

  MAUDE report 8211832 ↗
• MalfunctionMay 11, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2017-00085 FOR THE SECOND EVENT. FILL VOLUME: 400. FLOW RATE: 4ML/HR (2+2ML/HR). PROCEDURE:    LAPAROTOMY FOR SMALL BOWEL RESECTION. CATHPLACE:    PRE-PERITONEAL SPACE. A REPORT WAS RECEIVED FROM (B)(4) STATING THE CATHETER SNAPPED FOLLOWING A DIFFICULT REMOVAL. AFTER THE CATHETER WAS SUCCESSFULLY REMOVED IN ITS ENTIRETY, THERE WAS AN APPARENT TEAR TO THE CATHETER, WHICH IS LIKELY THE CAUSE OF THE DIFFICULT REMOVAL. ADDITIONAL INFORMATION RECEIVED 19-APR-2017 STATED THE CATHETER WAS SECURED WITH A SINGLE SUTURE. THE RESISTANCE LEVEL WAS RATED AT 5 ON CATHETER REMOVAL RESISTANCE RATING FROM 0 TO 5. THE CATHETER APPEARED TO BE STRETCHED. DURING REMOVAL, NO PART OF THE CATHETER APPEARED TO BE GRAYISH WHITE. ADDITIONAL INFORMATION RECEIVED 26-APR-2017 STATING THE PAIN BUSTER WAS INSERTED ON (B)(6) 2017 AND REMOVED (B)(6) 2017. THE INSERTION OF THE PAIN BUSTERS WENT IN WITHOUT ANY COMPLICATIONS. THE DEVICES WERE INSERTED INTO THE PRE-PERITONEAL SPACE WITH THE GUIDE NEEDLE AFTER REMOVING THE PLASTIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559511 ↗
• MalfunctionMay 11, 2017Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2017-00084 FOR THE FIRST EVENT. FILL VOLUME: 400; FLOW RATE: 4ML/HR (2+2ML/HR); PROCEDURE: LAPAROTOMY FOR SMALL BOWEL RESECTION. CATHPLACE: PRE-PERITONEAL SPACE. A REPORT WAS RECEIVED FROM THE UNITED KINGDOM STATING THE PAIN BUSTER COMPLETED EARLIER THAN EXPECTED. THE INFUSION WAS EXPECTED TO LAST AROUND 5-DAYS BUT WAS ACTUALLY COMPLETED IN 3-DAYS. THE CATHETER WAS REMOVED UNEVENTFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559510 ↗

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