# FDA recall Z-0921-2022

> **Abbott Vascular** · Class II · device recall initiated 2022-03-11.

## Product

20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)

## Reason for recall

Due to an increase in complaint trend for leaks and intermittent/loose connections.

## Distribution

U.S Nationwide Distribution.: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, VA, WA, and WI.    O.U.S.: United Arab Emirates, France, Pakistan, Argentina, United Kingdom, Portugal, Australia, Greece, R¿union, Belgium, Guam, Romania, Brazil, Indonesia, Russian Federation,  Bahamas, Israel, Saudi Arabia, Canada, India, Singapore, Switzerland, Italy, Slovakia, Chile, Jamaica, Thailand, China, Japan, Taiwan Republic of China, Colombia, Korea (South), Costa Rica, Luxembourg, Uruguay, Czech Republic, Mexico, Vietnam, Germany, Netherlands, South Africa, Dominican Republic, New Zealand, Spain, and Panama

## Key facts

- **Recall number:** Z-0921-2022
- **Recalling firm:** Abbott Vascular
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-11
- **Report date:** 2022-04-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Temecula, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0921-2022

## Citation

> AI Analytics. FDA recall Z-0921-2022. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0921-2022. Source: US FDA. Licensed CC0.

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