HEARTSTART XL+ DEFIBRILLATOR/MONITOR
by PHILIPS MEDICAL SYSTEMS
The HEARTSTART XL+ DEFIBRILLATOR/MONITOR by PHILIPS MEDICAL SYSTEMS has a safety score of 49 out of 100, placing it in the elevated-risk category. Based on FDA MAUDE data, there have been 8,525 adverse event reports including 30 deaths since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #174 out of 386 devices in the Cardiovascular category.
Should you be concerned? A safety score of 49/100 warrants careful consideration. With 8,525 adverse event reports and 30 associated deaths, the risk profile is elevated compared to alternatives in the cardiovascular category (which averages 67/100). Ask your doctor about alternative devices with better safety records.
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 HEARTSTART XL+ DEFIBRILLATOR/MONITOR
1. “What alternatives exist to the HEARTSTART XL+ DEFIBRILLATOR/MONITOR?”This device ranks #174 of 386 in the Cardiovascular category. There are 173 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 HEARTSTART XL+ DEFIBRILLATOR/MONITOR 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 Cardiovascular by safety score
How This Compares
Other Cardiovascular Devices
CORDIS CROWN STENT POWERGRIP DELIVERY SYSTEM
Unknown
CADENCE TIERED THERAPY DEFIBRILLATOR
Unknown
VENTAK PRX2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Unknown
HANCOCK II AORTIC HEART VALVE
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.