Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Recalled by Merit Medical Systems, Inc. Due to Due to a design issue, inflation syringe handle...

Date: June 10, 2021
Company: Merit Medical Systems, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Merit Medical Systems, Inc. directly.

Affected Products

basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

Quantity: 7,211 devices

Why Was This Recalled?

Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Merit Medical Systems, Inc.

Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report