ON-Q* Pain Relief SystemRecalls & reported problems across all models
Avanos Medical, Inc. · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 15 models of ON-Q* Pain Relief System by Avanos Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2018 and Apr 20, 2026 — classified as 4 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Break” (12 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ON-Q* Pain Relief System problems
Device problems
- Break12
- Infusion or Flow Problem5
- Adverse Event Without Identified Device or Use Problem4
- Excess Flow or Over-Infusion3
- Material Fragmentation2
- Fracture1
- Improper Flow or Infusion1
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient11
- No Known Impact Or Consequence To Patient5
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Bacterial Infection2
- Fever2
- No Consequences Or Impact To Patient2
- Purulent Discharge2
ON-Q* Pain Relief System models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ON-Q* Pain Relief System 13630Pump, infusion, elastomeric6 reports
- ON-Q* Pain Relief System 13627Pump, infusion, elastomeric5 reports
- ON-Q* Pain Relief System 13718Pump, infusion, elastomeric3 reports
- ON-Q* Pain Relief System 13603Pump, infusion, elastomeric2 reports
- ON-Q* Pain Relief System 13629Pump, infusion, elastomeric2 reports
- ON-Q* Pain Relief System 13701Pump, infusion, elastomeric2 reports
- ON-Q* Pain Relief System 13618Pump, infusion, elastomeric1 report
- ON-Q* Pain Relief System 13621Pump, infusion, elastomeric1 report
- ON-Q* Pain Relief System 13623Pump, infusion, elastomeric1 report
- ON-Q* Pain Relief System 13647Pump, infusion, elastomeric1 report
- ON-Q* Pain Relief System 13649Pump, infusion, elastomeric1 report
- ON-Q* Pain Relief System 13721Pump, infusion, elastomeric1 report
- ON-Q* Pain Relief System 13722Pump, infusion, elastomeric1 report
- ON-Q* Pain Relief System 45071Pump, infusion, elastomeric1 report
- ON-Q* Pain Relief System 47606Pump, infusion, elastomeric1 report
Recent ON-Q* Pain Relief System adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2023-00086 FOR THE FIRST EVENT. FILL VOLUME: UNKNOWN; FLOW RATE: UNKNOWN; PROCEDURE: UNKNOWN; CATHPLACE: UNKNOWN. IT WAS REPORTED THE "PUMP WAS REMOVED IN [A] HOSPITAL BEFORE DISCHARGED. THE WOUND SIDE HAD NO INFECTION. BUT WHEN PATIENT [TRAVELED], [THE PATIENT] REALIZED THAT [THE] WOUND WAS INFECTED...DID A CULTURE SWAB... AND IT WAS STAPH AUREUS." ADDITIONAL INFORMATION RECEIVED 24-JUL-2023 STATED THE PATIENT IS REPORTED TO BE WELL.
Patient problems: Bacterial Infection
MAUDE report 17483764 ↗InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2023-00087 FOR THE SECOND EVENT. FILL VOLUME: UNKNOWN; FLOW RATE: UNKNOWN; PROCEDURE: THBSO, OMENTECTOMY, APPENDECTOMY, AND NODAL SAMPLING; CATHPLACE: UNKNOWN. IT WAS REPORTED THE "PUMP WAS REMOVED IN [A]HOSPITAL BEFORE DISCHARGED. THE WOUND SIDE HAD NO INFECTION. BUT WHEN PATIENT [TRAVELED], [THE PATIENT] REALIZED THAT [THE] WOUND WAS INFECTED...DID A CULTURE SWAB... AND IT WAS STAPH AUREUS." ADDITIONAL INFORMATION RECEIVED 24-JUL-2023 STATED THE MEDICAL INTERVENTION ENTAILED "ASPIRATION OF THE HEMATOMA." THE PATIENT IS REPORTED TO BE WELL.
Patient problems: Bacterial Infection; Hematoma
MAUDE report 17483762 ↗MalfunctionJan 6, 2023Break; Break
IT WAS REPORTED TIT WAS REPORTED THAT THE ON-Q CATHETER BROKE DURING PATIENT USE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.
Patient problems: Insufficient Information
MAUDE report 16118367 ↗MalfunctionJan 6, 2023Break; Break
IT WAS REPORTED THAT THE ON-Q CATHETER BROKE DURING PATIENT USE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.
Patient problems: Insufficient Information
MAUDE report 16118127 ↗MalfunctionOct 29, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
FILL VOLUME: 300 ML, FLOW RATE: 4 ML/HR, PROCEDURE: ABDOMINOPLASTY, CATHPLACE: UNKNOWN, INFUSION START TIME: (B)(6) 2022, INFUSION STOP TIME: (B)(6) 2022. IT WAS REPORTED THAT AFTER BEING IN PLACE FOR 7 DAYS, THE ENTIRE PUMP INFUSED OVERNIGHT, (IT WENT FROM FULL CAPACITY TO COLLAPSED FLAT BY THE TIME THEY WOKE UP). THE PATIENT REPORTED WEAKNESS AND NAUSEA AFTER THE FAST FLOW INCIDENT, THE SYMPTOMS RESOLVED ON THEIR OWN; NO MEDICAL INTERVENTION REQUIRED. THE PATIENT WAS HOME AND WAS RECOVERED AS EXPECTED. THE ORIGINAL PROCEDURE WAS (B)(6) 2022.
Patient problems: Muscle Weakness/Atrophy; Nausea
MAUDE report 15694710 ↗MalfunctionSep 29, 2022Improper Flow or Infusion; Improper Flow or Infusion
FILL VOLUME: 300 ML, FLOW RATE: 5ML/HR, PROCEDURE: RENAL TRANSPLANT, CATHPLACE: UNKNOWN , INFUSION START TIME: ON (B)(6) 2022; 14:00, INFUSION STOP TIME: ON (B)(6) 2022; 7:00. THE LEAD NURSE REPORTED, A PUMP OVER-INFUSED, [THE INFUSION] SHOULD HAVE LASTED AROUND 60 HRS BUT THE BALL WAS EMPTY AT AROUND 41 HOURS POST-OP. THE PATIENT WAS CONFIRMED TO BE UNHARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15508263 ↗InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2022-00105 FOR THE SECOND EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNDERNEATH SUBCUTANEOUS. IT WAS REPORTED THE PATIENT EXPERIENCED AN EVENT OF A LARGE AMOUNT OF GREEN DISCHARGE, SEVERE FEVER AND EXOTHERMIC INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTIC INJECTION. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 STATED THE PATIENT HAS SINCE RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.
Patient problems: Fever; Purulent Discharge
MAUDE report 15465053 ↗InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00104 FOR THE FIRST EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNDERNEATH SUBCUTANEOUS. IT WAS REPORTED THE PATIENT EXPERIENCED AN EVENT OF A LARGE AMOUNT OF GREEN DISCHARGE, SEVERE FEVER AND EXOTHERMIC INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTIC INJECTION. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 STATED THE PATIENT HAS SINCE RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.
Patient problems: Fever; Purulent Discharge
MAUDE report 15464935 ↗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 ↗MalfunctionAug 18, 2022Break; Break
IT WAS REPORTED "THAT DURING THE REMOVAL OF THE CATHETER THE DISTAL END OF THE CATHETER WAS RETAINED IN THE PATIENT."(B)(6) THE CLINICIANS REMOVED BOTH CATHETERS, BOTH CATHETERS CAME OUT WITHOUT RESISTANCE, HOWEVER ONE OF THE CATHETERS DID NOT HAVE THE DISTAL BLACK TIP (THE OTHER DID). THERE ARE NO SIGNS OF PULLING ON THE CATHETER. "LEFT IN SITU DUE TO PATIENT CONDITIONS." THE CATHETER WAS SUTURED THROUGH.
Patient problems: Foreign Body In Patient
MAUDE report 15255094 ↗MalfunctionMay 23, 2022Break; Break
IT WAS REPORTED "THE PAINBUSTER CATHETER WAS CUT, LEAVING A 22CM-SIZED CATHETER IN THE PATIENT BODY, THEN REOPERATION PROCEEDED." ADDITIONAL INFORMATION RECEIVED 02-MAY-2022 STATING AFTER THE PATIENT'S MATERNAL CESAREAN SECTION, THE HEALTH CARE PROFESSIONAL PLACED THE CATHETER, AND THE NURSE REMOVED IT AFTER COMPLETING HER DRUG INJECTION. WHEN THE CATHETER BROKE AND IT REMAINED IN THE PATIENT'S BODY. A PROCEDURE WAS LATER PERFORMED TO RETRIEVE THE BROKEN CATHETER.
Patient problems: Foreign Body In Patient
MAUDE report 14474629 ↗MalfunctionMar 21, 2022Fracture; Fracture
IT WAS REPORTED THAT THERE WAS A CATHETER FAILURE INVOLVING A PATIENT AT (B)(6) HOSPITAL. THE REPORTER PROVIDED A PICTURE OF A CATHETER THAT WAS IN TWO PIECES: ONE LONG PIECE AND ONE SHORT PIECE WITH A BLACK TIP. THEY REPORT THAT IT WAS USED ON A PATIENT BUT THAT THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13841521 ↗MalfunctionFeb 23, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT UPON REMOVAL OF THE CATHETER FROM THE PATIENT THE TIP WAS DISCOVERED TO BE MISSING. A CT SCAN AND ULTRASOUND WERE PERFORMED, HOWEVER THEY WERE UNABLE TO FIND THE MISSING PIECE OF CATHETER INSIDE THE PATIENT. THERE WAS NO INJURY REPORTED. PER ADDITIONAL INFORMATION RECEIVED 9 FEB 2022, THE PATIENT'S CONDITION IS STABLE. THE PATIENT WAS RECEIVING ROPIVACAINE 2MG/ML IN SALINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13587018 ↗MalfunctionFeb 3, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
FILL VOLUME: 115 ML, FLOW RATE: UNKNOWN , PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE/TIME WHEN INFUSION STARTED: (B)(6) 2021, DATE/TIME WHEN INFUSION ENDED: (B)(6) 2021. IT WAS REPORTED THAT ALL THE MEDICINE INFUSED IN 18-HOURS, EARLIER THAN EXPECTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 13446417 ↗
Other Avanos Medical, Inc. products
- Halyard232 models · 1,210 reports · 1 recall
- Ballard* Closed Suction System30 models · 340 reports · 2 recalls
- Ballard* Turbo-Cleaning Closed Suction System16 models · 123 reports · 3 recalls
- Ballard* Closed Suction System for Adults17 models · 121 reports · 3 recalls
- CORTRAK* 2 Enteral Access System2 models · 134 reports · 1 recall
- Cortrak 2 Enternal access device14 models · 164 reports
- NEOMED*24 models · 0 reports · 3 recalls
- Microcuff* Endotracheal Tube for Adults8 models · 102 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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