GRANUFLO
by FRESENIUS MEDICAL GROUP
The GRANUFLO by FRESENIUS MEDICAL GROUP has a safety score of 32 out of 100, placing it in the high-risk category. Based on FDA MAUDE data, there have been 13,859 adverse event reports including 11372 deaths since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #6216 out of 6230 devices in the Other Devices category.
Should you be concerned? A safety score of 32/100 is a serious red flag. 13,859 adverse events including 11372 deaths have been reported. The incident rate of 0 per 10,000 units is significantly higher than comparable devices. We strongly recommend discussing alternatives with your healthcare provider before proceeding.
No recalls have been issued for this device — a positive indicator of manufacturing quality and design safety. On the market since 2015, this device has 11 years of real-world data — enough for long-term safety patterns to emerge.
Questions to Ask Your Doctor About the GRANUFLO
1. “What alternatives exist to the GRANUFLO?”This device ranks #6216 of 6230 in the Other Devices category. There are 6215 devices with better safety scores — ask if any are appropriate for your case.
2. “How many of these have you personally implanted or used?”Surgeon experience with a specific device significantly impacts outcomes. Higher procedure volume correlates with fewer complications.
3. “What are the specific risks for my case?”Overall adverse event rates (0 per 10,000) are averages — your individual risk depends on age, health conditions, and anatomy.
4. “Is there a newer generation of this device available?”The GRANUFLO has been on the market since 2015 (11 years). Newer versions may have improved safety profiles based on lessons from earlier models.
Adverse Events
Total reports filed with FDA MAUDE
Death Reports
Death reports associated with device
Incident Rate
Per 10,000 units in use
Recalls
No recalls on record
Estimated Units in Use
Based on market data estimates
Category Ranking
In Other Devices by safety score
How This Compares
Other Other Devices Devices
4MM ROUND BUR
Unknown
ABUTMENT: SHOULDERED, 2MM, INTEGRAL, 4.0
Unknown
ARROW WEDGE PRESSURE CATHETER
Unknown
AUTO SUTURE ABBI 20MM
Unknown
Important Context
Adverse event reports reflect reported incidents, not confirmed device failures. Higher numbers may indicate greater device usage, better reporting systems, or increased awareness. This data should be one factor in your research — always consult your physician.