ON-Q* Pain Relief System 47606Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30680651476068), received between Dec 12, 2018 and Dec 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 400 ML, FLOW RATE: 8 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED VIA FDA MEDWATCH MW5081190: "ONQ PUMP FILLED WITH ROPIVACAINE 0.2% 400 ML X2. PUMPS DISPENSED ON (B)(6) 2018 AT AROUND 1000. ORDERS PROFILED IN COMPUTER AS 8ML/HR OR EACH PUMP ON 2018 AT 1100. PT'S RN STATED THAT THE PUMP ON THE RIGHT SIDE WAS EMPTY. SURGEON WAS MADE AWARE AND CLAMPED THE PUMP. LOT NUMBER OF THE CLAMPED PUMP IS 02083660 . DATE OF USE 2018. IS THE PRODUCT COMPOUNDED? YES. IS THE PRODUCT OVER THE COUNTER? NO." NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8158595 ↗

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