ON-Q* Pain Relief System 13701Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193494137014), received between Sep 4, 2022 and Apr 20, 2026 — 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.

• MalfunctionApr 20, 2026Break; Material Separation

  THE CUSTOMER REPORTED THAT A PATIENT UNDERWENT SHOULDER SURGERY ON (B)(6) 2026 AND AN ON-Q PAIN PUMP CATHETER WAS PLACED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-APR-2026, REPORTING THAT DURING CATHETER REMOVAL ON (B)(6) 2026, THE PATIENT¿S CAREGIVER NOTED A ¿POP¿ AND THE CATHETER TIP WAS MISSING. THE PATIENT SUBSEQUENTLY UNDERWENT ARTHROSCOPIC SURGERY ON (B)(6) 2026 FOR REMOVAL OF A RETAINED CATHETER FRAGMENT (FOREIGN BODY). THE SURGEON SUCCESSFULLY RETRIEVED THE BROKEN CATHETER TIP, AND IT WAS NOTED THAT THE RETAINED SEGMENT CONTAINED A KNOT. THE PATIENT WAS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24932373 ↗
• MalfunctionSep 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PHYSICIAN USED THE ON-Q PUMP KIT FOR THE FIRST TIME ON (B)(6) 2022, THE CASE WAS A RIGHT FOOT LAPIDUS BUNIONECTOMY, TAILOR BUNIONECTOMY, EXTERNAL NEUROLYSIS DEEP PERONEAL NERVE WRAP, RELEASE OF NERVE ENTRAPMENT COMMON PERONEAL NERVE, RELEASE OF NERVE ENTRAPMENT TIBIAL NERVE AT SOLEAL SLING. THE DEVICE WAS PLACED INTRA-OPERATIVELY (100ML X 2ML/HOUR) ON TOP OF THE FOOT BETWEEN THE 2 BUNIONECTOMY INCISIONS. THE PHYSICIAN STATED, SHE WAS MADE AWARE BY A RADIOLOGIST THAT SOMETHING APPEARING TO BE A CATHETER WAS SHOWING ON THE POST OPERATIVE IMAGES OF THE PATIENT¿S FOOT. THE PHYSICIAN CONFIRMED THAT SHE PULLED THE SILVERSOAKER CATHETER HERSELF IN-CLINIC AND VERIFIED THAT SHE SAW THE BLACK TIP ON THE DISTAL END OF THE CATHETER. THERE WAS NO REPORTED INJURY AND THE PATIENT WAS NOTED TO BE DOING REALLY WELL AND HAD LESS POST-OPERATIVE PAIN THAN EXPECTED. ADDITIONAL INFORMATION RECEIVED ON 18AUG2022, THE PIECE OF THE SHEATH WAS REMOVED; THE PATIENT WAS REPORTEDLY ¿TOTALLY OK¿ A AND HAS NOT HAD ANY PAIN OR COMPLICATIONS SINCE THE ORIGINAL PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15353729 ↗

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