ON-Q* Pain Relief System with SELECT-A-FLOWRecalls & reported problems across all models
Avanos Medical, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 94
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 2 models of ON-Q* Pain Relief System with SELECT-A-FLOW by Avanos Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 94 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2020 and Jul 14, 2026 — classified as 11 injuries, 83 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (54 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 with SELECT-A-FLOW problems
Device problems
- Infusion or Flow Problem54
- Excess Flow or Over-Infusion23
- Adverse Event Without Identified Device or Use Problem8
- Improper Flow or Infusion8
- Application Program Problem: Medication Error1
- Fracture1
- Leak/Splash1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient50
- No Clinical Signs, Symptoms or Conditions16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Insufficient Information5
- Numbness5
- Inadequate Pain Relief3
- Nausea3
- Pain3
ON-Q* Pain Relief System with SELECT-A-FLOW models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ON-Q* Pain Relief System with SELECT-A-FLOW 13472Pump, infusion, elastomeric73 reports
- ON-Q* Pain Relief System with SELECT-A-FLOW* 13476Pump, infusion, elastomeric21 reports
Recent ON-Q* Pain Relief System with SELECT-A-FLOW adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Fracture; Material Separation
Patient problems: Foreign Body In Patient
MAUDE report 25811911 ↗MalfunctionJul 2, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
FILL VOLUME: UNKNOWN FLOW RATE: UNKNOWN PROCEDURE: STATUS POST TOTAL KNEE REPLACEMENT CATHPLACE: ABDUCTOR CANAL. IT WAS REPORTED, FACILITY EXPERIENCED FAST FLOW WITH ELASTOMERIC PUMP, THE PUMP EMPTIED IN LESS THAN 24-HOURS. THE PHYSICIAN IS NOT AWARE OF HOW MUCH FLUID WAS PLACED IN THE PUMP BEFORE STARTING THE INFUSION. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD NO COMPLAINTS OF PAIN; AFTER EVALUATION FROM ANESTHESIA, THE PHYSICIAN PLACED A DIFFERENT PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384200 ↗MalfunctionApr 22, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
FILL VOLUME: 600ML, FLOW RATE: (2-14ML), PROCEDURE: ROTATOR CUFF, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP WAS EMPTY. THE PATIENT WAS IN PAIN AND WAS TOLD THE PUMP WOULD LAST 60 MORE HOURS. THE ESTIMATED TIME PUMP WAS STARTED WAS FRIDAY, ON (B)(6) 2025, AT 0900 PUMP AT 10ML/HR. THE ESTIMATED TIME PUMP FINISHED WAS SUNDAY, ON (B)(6) 2025, AT NOON. THE PATIENT AND PATIENT'S SPOUSE VERBALIZED THEY DID NOT CHANGE THE RATE AT ANY POINT. THE PATIENT AND PATIENT'S SPOUSE WERE EDUCATED BY THE REGISTERED NURSE (RN) UPON DISCHARGE FROM THE HOSPITAL ON SATURDAY, ON (B)(6) 2025, THE PUMP STILL HAD 60-HOURS LEFT. THE PUMP HAD BEEN INFUSING FOR 24-HOURS ALREADY. THE RN ASSESSED THE PATIENT AND THERE WERE NO SIGNS AND SYMPTOMS NOTED FROM THE FAST FLOW EVENT. THERE WAS NO REPORTED INJURY.
Patient problems: Inadequate Pain Relief
MAUDE report 21882089 ↗MalfunctionMar 18, 2025Improper Flow or Infusion; Improper Flow or Infusion
FILL VOLUME: 550ML .2% ROPIVACAINE ML. FLOW RATE: 6ML PER HOUR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN PERINEURAL. INFUSION START TIME: ON (B)(6) 2025. INFUSION STOP TIME: ON (B)(6) 2025 AT 4AM. IT WAS REPORTED, THEY PLACED AN ON-Q PUMP ON FRIDAY, AND IT RAN DRY BY 4AM ON SUNDAY MORNING. NO REPORT OF ADVERSE EFFECT TO PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 13MAR2025, ¿CHANGED TO NEW ON Q. NO NERVE ISSUE.¿ NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634240 ↗MalfunctionNov 27, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
FILL VOLUME: UNKNOWN FLOW RATE: UNKNOWN PROCEDURE: UNKNOWN CATHPLACE: UNKNOWN IT WAS REPORTED THE PATIENT "WENT TO SLEEP AND WOKE UP SIX HOURS LATER TO AN EMPTY BALL AND A GIANT BALL OF FLUID IN HIS LEG (ADDUCTOR CANAL BLOCK)."
Patient problems: Foreign Body In Patient
MAUDE report 20799671 ↗MalfunctionSep 25, 2024Improper Flow or Infusion; Improper Flow or Infusion
FILL VOLUME: 360 ML. FLOW RATE: 6 ML/HR. PROCEDURE: PERIPHERAL NERVE BLOCK. CATHPLACE: LEFT FASCIA ILIACA BLOCK. INFUSION START TIME: (B)(6) 2024 1202. INFUSION STOP TIME: (B)(6) 2024 1600. IT WAS REPORTED, ¿PEDIATRIC PATIENT WHOSE PAIN PUMP RAN OUT EIGHT HOURS BEFORE IT WAS SUPPOSED TO. THE RATE HAD BEEN SET AND LOCKED AND THE PUMP WAS DELIVERING A HIGHER RATE SINCE IT RAN OUT TOO QUICKLY.¿ PER ADDITIONAL INFORMATION RECEIVED ON 16SEP2024, THE INCIDENT ¿RESULTED IN INCREASED PAIN WHICH HAD TO BE MANAGED BY INCREASING NARCOTIC AND NON-NARCOTIC MEDICATIONS WHILE PATIENT WAS AT HOME. PATIENT¿S MOTHER CALLED THE HOSPITAL AND SPOKE TO THE REGISTERED NURSE (RN) REGARDING THE SITUATION. MEDICAL DOCTOR (MD) WAS CALLED FOR PAIN MEDICATIONS TO HELP WITH INCREASED PAIN PATIENT WAS THEN EXPERIENCING.¿ ORAL MEDICATIONS PRESCRIBED WERE OXYCODONE, GABAPENTIN, TYLENOL, AND IBUPROFEN.
Patient problems: Insufficient Information
MAUDE report 20305461 ↗InjuryAug 14, 2024Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem; Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem
FILL VOLUME: UNKNOWN. FLOW RATE: 8-12CC/HR . PROCEDURE: RIGHT TOTAL KNEE ARTHROPLASTY (TKA). CATHPLACE: UNKNOWN . INFUSION START TIME: 02JUL2024. INFUSION STOP TIME: 04JUL2024. IT WAS REPORTED, SURGEON NOTIFIED THAT PATIENT WAS READMITTED TO HOSPITAL. PATIENT¿S CONTINUOUS ON-Q PUMP WAS DISCONTINUED, AND SEVERAL TESTS COMPLETED. SURGEON HAS DOCUMENTED THE PUMP WAS WORKING AS IT SHOULD. PER ADDITIONAL INFORMATION RECEIVED ON 22JUL2024, PATIENT HAD RIGHT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2024 AS AN OUTPATIENT. PATIENT COMMUNICATED WITH TEAM ON (B)(6)2024, DID OUTPATIENT PHYSICAL THERAPY ON (B)(6) 2024, AND WENT TO BED UNEVENTFULLY. PATIENT WAS FOUND UNRESPONSIVE ON (B)(6) 2024 AT 2PM. PATIENT WAS TAKEN BY EMS TO REGIONAL HOSPITAL WHERE SHE WAS INTUBATED, FOUND TO BE IN RENAL AND HEPATIC FAILURE. PATIENT WAS IN ICU WITH INTUBATION FOR 4 DAYS. PATIENT IMPROVED ON SUPPORTIVE CARE AND ORGAN SYSTEMS NORMALIZED. COGNITIVELY IMPROVING BACK TO BASELINE AS LAST VISIT. TRANSFERRED TO NURSING HOME FOR REHABILITATION. ICU TEAM TREATED AS LOCAL ANESTHETIC SYSTEMIC TOXICITY (LAST) PRESUMPTIVELY BUT ETIOLOGY UNCERTAIN. PICTURES OF PUMP WAS TAKEN SHOWING SOME FLUID REMAINING IN THE PUMP. IT WAS
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Level of Consciousness; Liver Failure; Renal Failure
MAUDE report 19983332 ↗MalfunctionJun 5, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED VIA FDA USER FACILITY REPORT MW REPORT (B)(4) AND THE FOLLOWING INFORMATION WAS PROVIDED: "BUPIVACAINE ONQ PUMP CB004 SET UP AND INITIATED AT APPROXIMATELY 14:00 TO INFUSE AT 10ML/HR FOR 55 HOURS AND END AT 23:00 2 DAYS LATER. UPON SPEAKING TO PATIENT, THE PUMP EMPTIED EARLY IN THE MORNING ESTIMATED AT 01:00. NO SIDE EFFECTS OR SYMPTOMS OF LOCAL ANESTHETIC SYSTEMIC TOXICITY (LAST). NURSE MANAGER INFORMED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19468212 ↗MalfunctionDec 28, 2023Improper Flow or Infusion; Improper Flow or Infusion
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2023-00113 FOR THE FIRST REPORT. REFER TO 2026095-2023-00115 FOR THE THIRD REPORT. FILL VOLUME: 600 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE PUMP EMPTIED AT LEAST A DAY PRIOR TO WHAT WAS EXPECTED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.
Patient problems: Insufficient Information
MAUDE report 18408676 ↗MalfunctionDec 28, 2023Improper Flow or Infusion; Improper Flow or Infusion
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2023-00113 FOR THE FIRST REPORT. REFER TO 2026095-2023-00114 FOR THE SECOND REPORT. FILL VOLUME: 600 ML . FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE PUMP EMPTIED AT LEAST A DAY PRIOR TO WHAT WAS EXPECTED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.
Patient problems: Insufficient Information
MAUDE report 18408675 ↗MalfunctionDec 28, 2023Improper Flow or Infusion; Improper Flow or Infusion
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2023-00114 FOR THE SECOND REPORT. REFER TO 2026095-2023-00115 FOR THE THIRD REPORT . FILL VOLUME: 600 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE PUMP EMPTIED AT LEAST A DAY PRIOR TO WHAT WAS EXPECTED. ONE PATIENT EXPERIENCED SYMPTOMS OF LOCAL ANESTHETIC SYSTEMIC TOXICITY (LAST). NO MEDICAL INTERVENTIONS REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18408670 ↗MalfunctionNov 2, 2023Leak/Splash; Improper Flow or Infusion; Material Split, Cut or Torn; Leak/Splash; Improper Flow or Infusion; Material Split, Cut or Torn
FILL VOLUME: 545 ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18060772 ↗MalfunctionSep 1, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
FILL VOLUME: 600 ML; FLOW RATE: 10ML/HR; PROCEDURE: FULL HYSTERECTOMY SURGERY; CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT "WOKE UP, PUMP WAS EMPTY. DIAL WAS ON 10[CC/HR]. [THE PATIENT] IS GOING TO REMOVE BUT CATHETER GLUED IN. ADVISED TO PLACE WARM MOIST TOWEL OVER SITE TO LOOSEN GLUE. [PATIENT] DENIES METAL TASTE, RINGING IN EARS OR NUMBNESS AROUND LIPS." THERE WAS NO REPORTED INJURY. THE PATIENT REPORTS " EXPERIENCING NO SYMPTOMS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17671686 ↗InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FILL VOLUME: 550 ML, FLOW RATE: UNKNOWN, PROCEDURE: TOTAL KNEE ARTHROPLASTY, CATHPLACE: ADDUCTOR CANAL, INFUSION START TIME: ON (B)(6) 2023, INFUSION STOP TIME: ON (B)(6) 2023. IT WAS REPORTED, PATIENT RECEIVED AN ADDUCTOR CANAL CATHETER PRE-OPERATIVELY FOR POST-OPERATIVE PAIN CONTROL FOLLOWING TOTAL KNEE ARTHROPLASTY ON (B)(6) 2023. PATIENT DISCHARGED HOME ON (B)(6) 2023 WITH ON-Q PUMP AND ADDUCTOR CANAL CATHETER IN PLACE. WHEN THE PATIENT ARRIVED HOME, THE PATIENT COMPLAINED OF RINGING IN THE EARS, METALLIC TASTE IN THE MOUTH, AND FEELING LIGHTHEADED. THE PUMP AND CATHETER WERE REMOVED, AND THE SYMPTOMS RESOLVED. NO INJURY REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dizziness; Tinnitus
MAUDE report 17324402 ↗MalfunctionJun 5, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
FLOW RATE: 2-14ML/HR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17060650 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page