Halyard 13630Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651136302), received between Jan 3, 2019 and Jan 8, 2020 — classified as 2 malfunctions.

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 18, 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.

• MalfunctionJan 8, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED 22-JAN-2020: "THE PRODUCT APPEARS TO BE USED IN ACCORDANCE WITH THE INSTRUCTIONS. DURING FILLING, TWO NURSES ARE PRESENT TO ENSURE PUMP IS NOT OVER OR UNDERFILLED. THE FLOW RATE RESTRICTOR OF FIXED FLOW PUMPS ARE SECURED TO THE PATIENT'S SKIN ON ABDOMEN. IT DOES NOT APPEAR THAT THE USER OR FACILITY CONDITIONS ARE CONTRIBUTORS TO THE INCIDENT. THIS IS AN EXPERIENCED CUSTOMER WITH STRINGENT PROTOCOLS AROUND USE OF THE ONQ PUMPS. THE DRUG USED WAS LEVOBUPIVACAINE 0.125%." ADDITIONAL INFORMATION RECEIVED ON 28-JAN-2020 INDICATED THAT THE CATHETER LOCATION WAS "SUBCUTANEOUS, LATERAL TO EITHER SIDE OF THE STERNUM." PROCEDURE WAS "PEDIATRIC CARDIAC."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9565647 ↗
• MalfunctionJan 3, 2019Break; Break

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: HERNIA REPAIR. CATHPLACE: ON TOP OF MESH IMPLANT ¿ WOUND INFUSION. IT WAS REPORTED THE CATHETER BROKE INTO TWO SEGMENTS, WHEN THE NURSE WAS REMOVING THE DEVICE POST RECOVERY. THE SURGEON WAS PLANNING TO LEAVE BROKEN PIECE "IN-SITU." THE BLACK MARKINGS WERE NOT PRESENT ON THE DEVICE WHEN IT WAS REMOVED. IT WAS ESTIMATED 20CM OF THE BROKEN CATHETER WAS RETAINED IN THE PATIENT WHEN THE DEVICE BROKE. DURING PLACEMENT THE DEVICE WAS INTRODUCED WITH A TROCAR. THE CATHETER WAS NOT SUTURED THROUGH AND WAS SECURED WITH SKIN GLUE. THE NURSE REMOVED THE CATHETER USING FINGERS. DURING REMOVAL THE CATHETER APPEARED TO BE CLEAN CUT, FURTHERMORE, THE OVERALL APPEARANCE OF THE CATHETER "LOOKED NORMAL." NO ADDITIONAL INFORMATION AS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8215653 ↗

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