# FDA recall Z-2166-2021

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2021-06-10.

## Product

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.

## Reason for recall

Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, ID, IL IN, KS, LA, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, WV, and WY. The countries of Australia, Austria, China, Denmark, Finland, France, Germany, Israel, Japan, Kenya, Kyrgyzstan, Netherlands, New Zealand, Norway, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.

## Key facts

- **Recall number:** Z-2166-2021
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-10
- **Report date:** 2021-08-04
- **Termination date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2166-2021

## Citation

> AI Analytics. FDA recall Z-2166-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2166-2021. Source: US FDA. Licensed CC0.

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