PrismaSATERecalls & reported problems across all models

We found 2 models of PrismaSATE by Baxter International Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Jan 16, 2026 and Jan 16, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

1 FDA recall record name at least one of these models by its device identifier.

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

PrismaSATE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 23, 2016Terminated

   Presence of leaks near top of the PrismaSate bags

   Z-2049-2016 · Root cause: Other · Recall details · FDA record ↗

Most reported PrismaSATE problems

PrismaSATE models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PrismaSATE 105351

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall0 reports
• PrismaSATE 107501

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 report

Recent PrismaSATE adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A "BROWN/RUST COLORED MARK ON THE INSIDE OF THE TUBE THAT THE BAG WAS SPIKED THROUGH" WAS OBSERVED ON A PRISMASATE BAG PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100286 ↗

Other Baxter International Inc. products

• CLEARLINK/CONTINU-FLO12 models · 824 reports · 6 recalls
• ONE-LINK12 models · 638 reports · 1 recall
• CLEARLINK19 models · 359 reports · 4 recalls
• INTRAVIA7 models · 455 reports
• CLEARLINK/DUO-VENT3 models · 150 reports
• INTERLINK17 models · 129 reports
• LOW RECIRCULATION VOLUME APD SET2 models · 69 reports
• Arthromatic/Uromatic3 models · 59 reports