530G INSULIN PUMP
by MEDTRONIC PUERTO RICO OPERATIONS CO.
The 530G INSULIN PUMP by MEDTRONIC PUERTO RICO OPERATIONS CO. has a safety score of 30 out of 100, placing it in the high-risk category. Based on FDA MAUDE data, there have been 59,081 adverse event reports including 487 deaths since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #219 out of 221 devices in the Diabetes category.
Should you be concerned? A safety score of 30/100 is a serious red flag. 59,081 adverse events including 487 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 530G INSULIN PUMP
1. “What alternatives exist to the 530G INSULIN PUMP?”This device ranks #219 of 221 in the Diabetes category. There are 218 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 530G INSULIN PUMP 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 Diabetes by safety score
How This Compares
Other Diabetes Devices
H-TRON V 100PLUS INSULIN INFUSION PUMP
Unknown
ULTRAFLEX SUBCUTANEOUS INSULIN INFUSION SET
Unknown
PUMP MMT-508UC EA INSULIN CH EN US
Unknown
BD PARADIGM LINK BLOOD GLUCOSE METER
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.