# FDA recall Z-0146-2023

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

## Product

Fogarty Arterial Embolectomy Catheters Model Number:  120602FP  120403FP   120803FP  120404FP  120804FP  120805FP  120806FP  120807FP    Fogarty Arterial Embolectomy Catheter with Stylet Model Number:  120403FSP  120803FSP

## 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-0146-2023
- **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-0146-2023

## Citation

> AI Analytics. FDA recall Z-0146-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0146-2023. Source: US FDA. Licensed CC0.

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