Halyard 13485Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651134858), received between Oct 24, 2017 and Oct 24, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2017Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 600 ML, FLOW RATE: 2 X 7 ML/HOUR (HR), CATHPLACE: ABDOMEN, DATE/TIME INFUSION START TIME: (B)(6) 2017 13:15, DATE/TIME INFUSION STOP TIME: (B)(6) 2017 21:10. IT WAS REPORTED THAT THE PUMP DELIVERED QUICKER THAN EXPECTED. THE PUMP HAD 600 MLS IN VOLUME AND THERE WAS 172 MLS DISCREPANCY IN A 32-HOUR PERIOD. THE RATE WAS SET AT 2 X 7 MLS/HR ( DUAL PUMP) . ADDITIONAL INFORMATION RECEIVED 10-OCT-2017 STATED THE DUAL PUMP DEVICE OVER ADMINISTERED 72 MLS OVER A 32-HOUR PERIOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6974771 ↗

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