WalkMed® 204821Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00859695006053), received between Jan 16, 2020 and Sep 5, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  A SEALED 150 ML INFUSION BAG (WALKMED ACCESSORY) WAS FOUND TO CONTAIN VISIBLE PARTICULATE MATTER PRIOR TO PATIENT USE. THE BAG WAS QUARANTINED; NO PATIENT EXPOSURE AND NO HARM WERE REPORTED. INVESTIGATION IS OPEN; EXTERNAL LABORATORY IDENTIFICATION/COUNT OF PARTICULATES IS PENDING. LOT HISTORY, COA, AND INCOMING INSPECTION RECORDS ARE UNDER REVIEW. THIS INITIAL MDR IS SUBMITTED AS A MALFUNCTION DUE TO THE POTENTIAL FOR SERIOUS INJURY IF UNDETECTED PARTICULATE WERE INFUSED. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL SIGNIFICANT INFORMATION. INITIAL REPORT SUBMITTED AFTER 30 DAYS DUE TO ESUBMITTER/ADOBE/CERTIFICATE ISSUES, NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986876 ↗
• MalfunctionJan 2, 2024Precipitate in Device or Device Ingredient; Precipitate in Device or Device Ingredient

  FACILITY CALLED HOTLINE TO REPORT THAT THEY HAVE A BAG WITH "PARTICLES" IN IT. NO PICTURES WERE PROVIDED AND BAG WAS DISPOSED OF SO COULD NOT BE RETURNED. THE REST OF THE BAGS IN THAT LOT HAVE BEEN ISOLATED AND PUT TO THE SIDE, WALKMED REQUESTED THESE BAGS AND HAS RECIEVED THEM. THERE WAS NO PATIENT IMPACT SINCE THE PARTICULATE WAS IDENTIFIED IN THE BAG DURING SETUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427805 ↗
• MalfunctionJun 18, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  CLINIC REPORTED "I FOUND ANOTHER PARTICLE, OF THE SAME SORT THAT I DESCRIBED IN DECEMBER, IN A PUMP BAG THAT I WAS CHECKING." (IN REFERENCE TO ADDITIONAL COMPLAINT REPORTED ON 3000204189-2020-00001) SHE ALSO REPORTED "OF COURSE, FLUOROURACIL DOES CRYSTALIZE, SO IT'S POSSIBLE IT COULD BE A DRUG PARTICLE, BUT I CHECK THE VIALS AND THE TECH DOUBLE CHECKS THEM FOR ANY CRYSTALLIZATION BEFORE MIXING AND WE DIDN'T SEE ANY AFTER DRUG HAD BEEN PUT IN. I DON'T THINK IT WOULD HAVE BEEN LIKELY TO SEE IT BEFORE MIXING, BECAUSE IT IS TINY AND WHITE TO TRANSLUCENT. I DON'T THINK IT'S A FLUOROURACIL CRYSTAL THOUGH, BECAUSE THOSE SINK IN THE FLUOROURACIL SOLUTION AND THIS PARTICLE FLOATS." BAG WAS DISPOSED OF AFTER IDENTIFYING THE PARTICULATE. ADDITIONAL BAGS FROM THIS LOT WERE SENT TO WALKMED FOR REVIEW AND NO ADDITIONAL PARTICULATE WAS IDENTIFYING DURING TESTING. NO INTERNAL NON-CONFORMING REPORTS OR ADDITIONAL CUSTOMER RELATED COMPLAINTS HAVE EVER BEEN IDENTIFIED FOR PARTICULATE.

  Patient problems: No Patient Involvement

  MAUDE report 10171202 ↗
• MalfunctionJan 16, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE CLINIC STATED THAT DURING SETUP, "PARTICLES" WERE OBSERVED IN SEVERAL IPR 150 MEDICATION RESERVOIRS AFTER OPENING THE BAG AND ALSO FILLING. NO MEDICAL INTERVENTION OR INJURY REPORTED. PRODUCT WAS MISPLACED AT THE FACILITY AND THEREFORE WILL NOT BE RETURNED FOR INVESTIGATION. THIS IS A FIRST TIME OCCURRENCE FOR THIS ISSUE FOR THIS PRODUCT.

  Patient problems: No Patient Involvement

  MAUDE report 9597933 ↗