Gambro Healthcare
FDA adverse event reports naming Gambro Healthcare as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: GAMBRO HEALTHCARE.
- Total reports
- 1,266
- Deaths
- 18
- Injuries
- 212
- Malfunctions
- 1,010
Reports per year
30396
54897
30298
10399
100
201
102
204
205
206
Source: FDA adverse event reports by year received, 1996–2006. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- System, Dialysate Delivery, SealedFII1,030
- Set, Tubing, Blood, With And Without Anti-Regurgitation ValveFJK107
- Dialyzer, Capillary, Hollow FiberFJI52
- Dialyzer, Parallel FlowFJG34
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)KPO14
- Dialyzer, High Permeability With Or Without Sealed Dialysate SystemKDI10
- System, Dialysate Delivery, Single PatientFKP9
- Needle, FistulaFIE5
- Set, Blood TransfusionBRZ2
- Product code 1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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