# FDA recall Z-0420-2020

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2019-10-22.

## Product

EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI):   EZC21A (00690103174182),   EZC21TA (00690103174199),   EZC24A (00690103714401),   EZC24TA (00690103714418),   EZF21A (00690103175080),  EZF21TA (00690103175097),  EZF24A (00690103175066),   EZF24TA (00690103175073),   EZS21A (00690103172096),   EZS21TA (00690103172102),   EZS24A  (00690103172119),   and EZS24TA (00690103172126)  Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.

## Reason for recall

Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas,  Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming and countries of Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Chile, China, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hungary, Canary Islands, Ireland, India, Iceland, Italy, Japan, Mauritius, Malaysia, Netherlands, Norway, Poland, Romania, Sweden, Singapore, Slovakia, Thailand, Turkey, United Arab Emirates, South Africa.

## Key facts

- **Recall number:** Z-0420-2020
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-22
- **Report date:** 2019-11-27
- **Termination date:** 2022-06-29

- **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-0420-2020

## Citation

> AI Analytics. FDA recall Z-0420-2020. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0420-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*