Baxter HomeChoice Peritoneal Dialysis Systems Recalled for Software Defect
Baxter is recalling HomeChoice and HomeChoice PRO automated peritoneal dialysis systems due to a software defect that may cause serious complications in patients with ascites.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the defect 'can cause serious problems' in patients with ascites, and the agency classification is Class II, which aligns with the 'Severe' rubric criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Baxter Healthcare Corp. is recalling approximately 65,590 units of HomeChoice and HomeChoice PRO automated peritoneal dialysis systems. The recall affects product codes 5C4471, 5C4471R, 5C8310, and 5C8310R, covering all serial numbers. These devices are intended for the automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
The recall is due to a software defect in systems with version 10.4 software Initial Drain logic. The device attempts to drain the patient to empty at the beginning of therapy, a process the operator can stop but cannot bypass. This design is intended to mitigate Unintended Increased Intraperitoneal Volume (IIVP) but can cause serious problems in patients who have an unrelated co-morbid condition of ascites.
The affected units were distributed worldwide, including the United States (nationwide including Puerto Rico), Australia, Canada, New Zealand, and Japan. Patients and healthcare providers should contact Baxter Healthcare Corp. for instructions on how to proceed with the recall and ensure patient safety.
The recalled product
- Product
- 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automa
- Manufacturer
- Baxter Healthcare Corp.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: All serial numbers
Distribution
Related recalls
Same manufacturer · Baxter Healthcare Corp.
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25