# FDA recall Z-2224-2019

> **Edwards Lifesciences, LLC** · Class I · device recall initiated 2019-07-09.

## Product

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System)  (20 mm) 9630TF20   UDI:00690103201239

## Reason for recall

The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures

## Distribution

US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS  OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany,  Finland, Denmark, Canary Islands, Canada, Austria

## Key facts

- **Recall number:** Z-2224-2019
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-09
- **Report date:** 2019-08-28
- **Termination date:** 2020-09-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2224-2019

## Citation

> AI Analytics. FDA recall Z-2224-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2224-2019. Source: US FDA. Licensed CC0.

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