THERANOVA 500Recalls & reported problems
Gambro Dialysatoren GmbH · Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed during intermittent HD. Dialyzers provide increased removal of various conventional middle (500 Da - <25 kDa) & large middle (25 - 45 kDa) molecules compared to HF membranes. Performances are achieved using existing HD workflow and infrastructure. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07332414125721), received between Oct 29, 2025 and Oct 29, 2025 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Back pain1
- Chest Pain1
- Cough1
- Dyspnea1
- Hypersensitivity/Allergic reaction1
- Hypoxia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING TREATMENT WITH AN UNSPECIFIED THERANOVA DIALYZER, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND CHEST PAIN. IT WAS FURTHER REPORTED THAT THIS WAS THE FIRST TIME THE PATIENT HAD USED A THERANOVA DIALYZER. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ACCORDING TO THE REPORTER, THE ¿SYMPTOMS RESOLVING AFTER ENDING THERAPY¿. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Back pain; Chest Pain; Cough; Dyspnea; Hypersensitivity/Allergic reaction; Hypoxia
MAUDE report 23415685 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.