# FDA recall Z-0147-2023

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2022-10-06.

## Product

Fogarty Biliary Balloon Probes Model Number:  410235FP  410405FP  410236FP

## Reason for recall

Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bulgaria, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guam, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Malta, Mauritius, Morocco, Netherlands, Nicaragua, Northern Ireland, Oman, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates (UAE), United Kingdom.

## Key facts

- **Recall number:** Z-0147-2023
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-06
- **Report date:** 2022-11-09

- **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-0147-2023

## Citation

> AI Analytics. FDA recall Z-0147-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0147-2023. Source: US FDA. Licensed CC0.

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