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Abbott Medical recalls Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Recalled July 31, 2024 · FDA recall Z-2429-2024 · Abbott Medical
Hazard
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. · FDA Class II
Units
5,900 units
Sold at
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.
Description
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.
Product
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Manufacturer(s)
Abbott Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →