WalkMed® 204609Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00859695006077), received between Jun 22, 2018 and Aug 27, 2025 — classified as 1 death, 17 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (3 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• DeathAug 27, 2025Pressure Problem; Pressure Problem

  A PATIENT UNDERGOING HOME INFUSION THERAPY USING A WALKMED 350VL AMBULATORY INFUSION PUMP (SERIAL NUMBER (B)(6)) EXPERIENCED CARDIAC ARREST ON (B)(6) 2025, WHILE RECEIVING 5-FU VIA CONTINUOUS INFUSION. THE PATIENT'S SPOUSE INITIATED CPR, AND EMERGENCY RESPONDERS PROVIDED FURTHER RESUSCITATION, BUT THE PATIENT WAS LATER PRONOUNCED DECEASED ON (B)(6) 2025 11:15 PM. THE INFUSION PUMP WAS STILL CONNECTED AT THE TIME OF THE EVENT. TIME OF DEATH DECLARED 22:15 PM (EXTENSIVE DOWNTIME) THE REPORTING FACILITY, VIA DISTRIBUTOR INFUSYSTEM, LATER INDICATED THAT THE CAUSE OF DEATH WAS DETERMINED TO BE A PULMONARY EMBOLISM AND DID NOT ATTRIBUTE THE OUTCOME TO A DEVICE MALFUNCTION. HOWEVER, DUE TO THE CIRCUMSTANCES, THE DEVICE WAS RETURNED TO WALKMED UNDER RGA #(B)(4) FOR EVALUATION. WALKMED CONDUCTED A VISUAL AND FUNCTIONAL EVALUATION PER SOP 100-601 USING FORM 100-601F6. THE PUMP FAILED PRESSURE PERFORMANCE TESTING AND EXHIBITED CLAMP BAR MALALIGNMENT, RESULTING IN IMPAIRED OCCLUSION DETECTION AND AN OUT-OF-SPEC PRESSURE PROFILE. THESE FINDINGS CONFIRM THAT THE DEVICE WAS NOT FUNCTIONING WITHIN DESIGN SPECIFICATIONS AT THE TIME OF EVALUATION. ALTHOUGH A DEFINITIVE CAUSAL LINK TO THE PATIENT'S D

  Patient problems: Pulmonary Embolism

  MAUDE report 22907469 ↗
• MalfunctionApr 11, 2019Insufficient Flow or Under Infusion

  CALL RECEIVED FROM THE HOME IV NURSE STATING THAT SHE WAS AT THE PATIENT'S HOME TO DISCONNECT THE PATIENT FROM HIS PUMP. PUMP READ EMPTY, PATIENT WAS DISCONNECTED AND THEN THE NURSE REALIZED NONE OR LITTLE OF THE INTENDED MED HAD BEEN INFUSED. PATIENT CAME TO THE CLINIC WITH HIS PUMP AND THE UNINFUSED BAG OF CHEMO IN THE (B)(6) BAG. MED DISCARDED AND COVERING PHYSICIAN MADE AWARE. PATIENT AWARE, NO READMINISTRATION OF MEDICATION AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8503358 ↗
• MalfunctionMar 11, 2019Device Displays Incorrect Message; Output Problem

  PATIENT CAME TO CLINIC TO EVALUATE PUMP MALFUNCTION. WALKMED 350VL (B)(4). PUMP ALARMED AT 0300. PATIENT TRIED CHANGING BATTERY AND CALLED INFU SYSTEM SUPPORT WHEN PUMP CONTINUED TO ALARM. HE WAS INSTRUCTED TO CLAMP PUMP AND COME TO CLINIC IN AM. PORT WITH POSITIVE BLOOD RETURN. PUMP INFUSED 11 HRS BEFORE ALARMING. WHEN PUMP CHECKED MESSAGE DISPLAYED ER U (SYSTEM MALFUNCTION). NEW PUMP WAS ISSUED TO PATIENT AND INFUSION RATE ADJUSTED TO FINISH IN 46 HRS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8407251 ↗
• MalfunctionDec 19, 2018No Audible Alarm; Loss of Power

  PATIENT INFORMED NURSE INFUSION PUMP WAS OFF AT 0145 WHICH WAS NOTICED BY THE RN WHO ARRIVED AT HER HOUSE FOR 5FU INFUSION DISCONNECT. THE PATIENT DID NOT HEAR ANY ALARMS. NURSING PLACEMENT REPLACED BATTERY AND PUMP STARTED RUNNING. THE PATIENT HAD 18 HRS LEFT TO INFUSE. HE RETURNED TO PATIENT'S HOUSE THE NEXT MORNING AND DISCONNECTED PUMP WHEN 5FU HAD FINISHED INFUSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8178326 ↗
• MalfunctionDec 19, 2018Defective Device

  PATIENT STATES INFUSYSTEM PUMP WAS BEEPING AT 0130, CALLED THEIR 1-800 NUMBER AND WAS TOLD TO SHUT PUMP OFF AND CALL OUR CLINIC. PUMP WAS BEEPING ER.U, WHICH MEANS A PUMP MALFUNCTION. GAVE PATIENT A NEW PUMP, TREATMENT DELAYED 8.5 HOURS.

  Patient problems: No Code Available

  MAUDE report 8178317 ↗
• MalfunctionDec 5, 2018Insufficient Flow or Under Infusion

  PATIENT ARRIVED IN CLINIC FOR PUMP DISCONNECT. PATIENT SHOULD HAVE RECEIVED TRABECTEDIN IN 500 ML OVER 24 HOURS. WHEN PATIENT ARRIVED IN CLINIC, TRABECTEDIN BAG WAS FULL. PUMP SET TO INFUSE AT 22.7 ML/HR AND PUMP SHOWING 480 ML OF 501 ML INFUSED BUT BAG IS FULL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8132736 ↗
• MalfunctionNov 28, 2018No Flow; Application Program Problem: Medication Error

  PATIENT CALLED INTO THE CLINIC AFTER NOT BEING ABLE TO TROUBLE SHOOT THE ISSUE OF HIS HOME INFUSION PUMP EVEN AFTER CALLING THE 800 NUMBER ON THE PUMP. UPON ARRIVAL, THE PUMP WAS NOT INFUSING AND HAD DELETED THE SET PROGRAM. A NEW PUMP WAS ISSUED AND PATIENT CONTINUED WITH HIS INFUSION. INTERRUPTION OF INFUSION LASTED APPROX. 1 1/2 HOURS. MD MADE AWARE- NO HARM TOWARDS PATIENT NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8109908 ↗
• MalfunctionNov 20, 2018Pumping Problem

  5FU INFUSION WALKMED PUMP MALFUNCTIONED OVER NIGHT RESULTING IN LATE MEDICATION COMPLETION TIME.

  Patient problems: No Information

  MAUDE report 8089707 ↗
• MalfunctionNov 20, 2018Pumping Problem

  PATIENT'S AMBULATORY INFUSION PUMP FOR HOME CHEMOTHERAPY WAS FOUND TO BE MALFUNCTIONED. THE INFUSION PUMP WAS NOT KEEPING THE SETTINGS THAT WAS PROGRAMMED ON THE PUMP FOR THE CHEMOTHERAPY INFUSION. NEW INFUSION WAS ISSUED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8089643 ↗
• MalfunctionNov 20, 2018Mechanical Problem

  PATIENT REPORTED PUMP NOT WORKING AT 3 AM - CALLED COMPANY NUMBER ON THE PUMP AND THEY SUGGESTED REPLACING THE BATTERY, WHICH PATIENT DID DO BUT DID NOT CORRECT THE ISSUE. PATIENT COMES INTO THE CLINIC FIRST THING THE NEXT MORNING FOR EVALUATION AND A NEW PUMP WAS ISSUED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8089642 ↗
• MalfunctionNov 20, 2018Failure to Infuse

  PATIENT CALLED INTO THE CLINIC AFTER NOT BEING ABLE TO TROUBLE SHOOT THE ISSUE OF HIS HOME INFUSION PUMP EVEN AFTER CALLING THE 800 NUMBER ON THE PUMP. UPON ARRIVAL, THE PUMP WAS NOT INFUSING AND HAD DELETED THE SET PROGRAM. A NEW PUMP WAS ISSUED AND PATIENT CONTINUED WITH HIS INFUSION. INTERRUPTION OF INFUSION LASTED APPROX. 1 1/2 HOURS. DOCTOR MADE AWARE- NO HARM TOWARDS PATIENT NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8089593 ↗
• MalfunctionNov 20, 2018Infusion or Flow Problem

  PATIENT CALLED CLINIC THIS MORNING STATING THAT HIS 5FU CIVI PUMP WAS BACKED UP WITH BLOOD FROM PORT TUBING INTO INFUSION BAG. HE NOTICED THIS LAST EVENING. THE INFU SYSTEM PUMP (WALK MED 350) HAD JUST STOPPED WORKING AND DID NOT ALARM. THE FACE OF THE PUMP DID HAVE DIGITAL READINGS BUT WAS NOT INFUSING. HE CAME TO CLINIC FOR EVALUATION. NEW PUMP WAS ASSIGNED. REMAINING DRUG DOSAGE WAS RECALCULATED AND NEW BAG CONNECTED. PORT HAD TO BE REACCESSED SINCE IT WAS UNABLE TO FLUSH. UNABLE TO ASSESS HOW LONG PUMP WAS NOT INFUSING AS THERE WAS NO ALARM FOR PATIENT TO BE AWARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8089568 ↗
• MalfunctionNov 20, 2018No Display/Image

  PATIENT REPORTED AMBULATORY INFUSION 5-FU PUMP MALFUNCTIONED THE DAY BEFORE. RECEIVED A CALL IN THE CLINIC FROM THE REGISTERED NURSE FROM NURSING PLACEMENT WHO WENT TO THE PATIENT'S HOUSE TO DISCONNECT HER, HE FOUND THE SCREEN ON THE PUMP 'BLACK'. THEY REPLACED THE BATTERY AND SCREEN WAS STILL BLACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8089500 ↗
• MalfunctionNov 20, 2018Complete Blockage

  PATIENTS DAUGHTER CALLED STATING 5FU PUMP STARTED ALARMING LAST NIGHT AROUND 1200. PUMP READING OCCLUSION. SHE CALLED NUMBER ON PUMP. UNABLE TO TROUBLESHOOT PUMP. ADVISED TO SHUT PUMP OFF AND CALL CLINIC IN AM AND HAVE PUMP EVALUATED IN CLINIC WHICH SHE DID.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8089496 ↗
• MalfunctionNov 14, 2018Device Displays Incorrect Message

  PATIENT CALLED CLINIC TO INFORM NURSE THAT INFU SYSTEM PUMP WAS ALARMING AT HOME. PATIENT CAME TO CLINIC, PUMP SCREEN FLASHING 'ERR.U', ACCORDING TO MANUFACTURER TROUBLE SHOOTING GUIDE THIS IS A SYSTEM MALFUNCTION AND PUMP NEEDS TO BE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8068512 ↗
• MalfunctionNov 14, 2018Defective Device

  PATIENT CALLED TO INFORM US INFUSYSTEM 5 FU PUMP WAS NOT WORKING. SHE CALLED 1-800 NUMBER AND THEY INSTRUCTED HER TO COME TO CLINIC FOR NEW PUMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8068511 ↗
• MalfunctionSep 25, 2018Defective Component

  PATIENT'S INFUSION HOME PUMP MALFUNCTIONED. PATIENT CONTACT VENDOR TO TROUBLESHOOT. VENDOR TOLD PATIENT TO TURN THE PUMP OFF. PATIENT LACKED COMPLETING DOSAGE BY 16.22 CC'S.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7905069 ↗
• MalfunctionJun 22, 2018Device Inoperable; Device Displays Incorrect Message

  PATIENT CAME TO THE CLINIC FOR FOLFIRI TREATMENT. SHE WAS DISCHARGED HOME ON HER CIVI OF 5 FU. THE FOLLOWING DAY WHILE SHE WAS OUT RUNNING ERRANDS HER PUMP MALFUNCTIONED AND STOPPED WORKING FOR ABOUT HALF AN HOUR. PUMP READ "IDLE" AT THAT TIME. SHE DID CALL THE COMPANY AND WAS ABLE TO GET HER INFUSION RUNNING. SHE COMPLETED HER INFUSION WITHOUT FURTHER INCIDENT. SHE CALLED THE CLINIC AFTER SHE GOT HER PUMP RUNNING TO LET US KNOW THAT HER PUMP HAD MALFUNCTIONED. HER DISCONNECT TIME WAS ADJUSTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7629356 ↗