# FDA recall Z-0735-2021

> **Boston Scientific Corporation** · Class I · device recall initiated 2020-11-17.

## Product

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.

## Reason for recall

Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.

## Distribution

Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV.  Government distribution was also made.    Foreign distribution was made to Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, and Switzerland.

## Key facts

- **Recall number:** Z-0735-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-17
- **Report date:** 2021-01-20
- **Termination date:** 2022-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0735-2021

## Citation

> AI Analytics. FDA recall Z-0735-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0735-2021. Source: US FDA. Licensed CC0.

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