# FDA recall Z-2430-2024

> **Abbott Medical** · Class II · device recall initiated 2024-05-22.

## Product

Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only

## Reason for recall

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially  resulting in loss of therapy.

## Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, WA, WI, WY and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, 	Czech Republic, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-2430-2024
- **Recalling firm:** Abbott Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-22
- **Report date:** 2024-07-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plano, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2430-2024

## Citation

> AI Analytics. FDA recall Z-2430-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2430-2024. Source: US FDA. Licensed CC0.

---

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