VALIANT CAPTIVIA - CW

by Unknown

Other DevicesFDA 510kOn market since 2015
57
Elevated

The VALIANT CAPTIVIA - CW by Unknown has a safety score of 57 out of 100, placing it in the elevated-risk category. Based on FDA MAUDE data, there have been 195 adverse event reports including 100 deaths since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #5785 out of 6230 devices in the Other Devices category.

Should you be concerned? A safety score of 57/100 warrants careful consideration. With 195 adverse event reports and 100 associated deaths, the risk profile is elevated compared to alternatives in the other devices category (which averages 72/100). 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 VALIANT CAPTIVIA - CW

1. “What alternatives exist to the VALIANT CAPTIVIA - CW?”This device ranks #5785 of 6230 in the Other Devices category. There are 5784 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 VALIANT CAPTIVIA - CW has been on the market since 2015 (11 years). Newer versions may have improved safety profiles based on lessons from earlier models.

Adverse Events

195

Total reports filed with FDA MAUDE

Death Reports

100

Death reports associated with device

Incident Rate

0

Per 10,000 units in use

Recalls

0

No recalls on record

Estimated Units in Use

0

Based on market data estimates

Category Ranking

#5785 of 6230

In Other Devices by safety score

How This Compares

Safety Score57/100
Category Average
72
This Device
57
Best in Category
84

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.