FLEXIFLO III ENTERAL NUTRITION PUMP

by Unknown

Infusion PumpsFDA 510kOn market since 2015
79
Moderate

The FLEXIFLO III ENTERAL NUTRITION PUMP by Unknown has a safety score of 79 out of 100, placing it in the moderate-risk category. Based on FDA MAUDE data, there have been 88 adverse event reports since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #58 out of 234 devices in the Infusion Pumps category.

Should you be concerned? A score of 79/100 indicates moderate safety. The 88 adverse event reports should be viewed in context — higher reporting doesn't always mean a more dangerous device, as popular devices naturally accumulate more reports. However, discuss the specific risks with your doctor before your procedure.

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 FLEXIFLO III ENTERAL NUTRITION PUMP

1. “What alternatives exist to the FLEXIFLO III ENTERAL NUTRITION PUMP?”This device ranks #58 of 234 in the Infusion Pumps category. There are 57 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 FLEXIFLO III ENTERAL NUTRITION 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

88

Total reports filed with FDA MAUDE

Death Reports

0

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

#58 of 234

In Infusion Pumps by safety score

How This Compares

Safety Score79/100
Category Average
73
This Device
79
Best in Category
83

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.