Sharesource Connectivity PlatformRecalls & reported problems across all models
Baxter International Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 3 models of Sharesource Connectivity Platform 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 Mar 30, 2026 and Mar 30, 2026 — classified as 1 injury.
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
Reports received per month, all models
Sharesource Connectivity Platform 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.
- Jun 30, 2021Terminated
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
Z-2173-2021 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported Sharesource Connectivity Platform problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Sharesource Connectivity Platform models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sharesource Connectivity Platform 5C9400System, peritoneal, automatic delivery1 recall0 reports
- Sharesource Connectivity Platform 5C9400System, peritoneal, automatic delivery1 recall0 reports
- Sharesource Connectivity Platform 5C9400SYSTEM, PERITONEAL, AUTOMATIC DELIVERY1 report
Recent Sharesource Connectivity Platform adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TWO AUTOMATED PERITONEAL DIALYSIS (PD) PATIENTS USING KAGUYA CYCLERS WITH SHARESOURCE WERE HOSPITALIZED DUE TO "FLOODING", FURTHER DESCRIBED AS "OUTFLOW MODE". THE REPORTER FURTHER INFORMED THAT DIFFICULTY WAS ENCOUNTERED WITH SOME OF THE PARAMETERS PROGRAMMED IN SHARESOURCE, INCLUDING THE "DISCONNECT STATE", WHEREBY PATIENTS SEEM TO END THERAPY "STILL FLOODED". THERE WAS NO REPORT OF PATIENT SYMPTOMS. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO PROVIDE DETAILS ABOUT THE EVENT.
Patient problems: Insufficient Information
MAUDE report 24716961 ↗
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
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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