ON-Q* Pain Relief System 13722Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193494137229), received between Jun 12, 2020 and Jun 12, 2020 — classified as 1 malfunction.

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

• MalfunctionJun 12, 2020Break; Break

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: LEFT FOOT BUNIONECTOMY. CATHPLACE: LEFT FOOT. DATE PROCEDURE: (B)(6) 2020. IT WAS REPORTED AN ON-Q CATHETER KINKED. THE SURGEON WAS UNABLE TO REMOVE THE CATHETER IN THE OFFICE. THE PATIENT REQUIRED A RETURN VISIT TO THE OPERATING ROOM TO HAVE THE CATHETER REMOVED. WHILE THE CATHETER WAS IN PLACE THE PATIENT'S PAIN WAS "WELL CONTROLLED" AND "THE BALL LOOKED LIKE IT INFUSED THE MEDICATION." THE CATHETER WAS REMOVED IN SURGICAL SETTING AND NOTED TO BE IN TWO PIECES. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10148889 ↗

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