ON-Q* Pain Relief System 13621Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193494136215), received between Dec 28, 2021 and Dec 28, 2021 — 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.

• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED "THE SHEATH BROKE AWAY AT THE BLUE TIP, AND THE ENTIRE SHEATH WAS LEFT INSIDE THE PATIENT." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 16-DEC-2021 STATED, "THE SURGEON CLOSED THE WOUND THEN INSERTED THE NEEDLE WITH THE T-PEEL SHEATH ON IT, HENCE THE SHEATH REMAINED IN THE PATIENT. APPARENTLY, THE NEEDLE PIERCED A READY VAC-DRAIN AS THE SURGEON WENT IN BLIND." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13102044 ↗

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