FDA-Device2013-07-03Class II
Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
Medtronic Inc. Cardiac Rhythm Disease Management
Hazard
Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specifi
Sold states
Worldwide Distribution - USA including CA, FL, GA, KY, LA, LMN, MO, NE, NY, OK, PA, TN, TX, WI, and PR and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Latvia, Lebanon, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia ,United Arab Emirates, United Kingdom, Uruguay , and Yemen. UPDATED Physicians location in USA: AL, AR, FL, GA, IL, IN, KS. LA, ME, MI, MN, MO, NY, OH, PA, SC, TN, TX and VA. OUS: Luxembourg
Affected count
1912 (159 USA & 1137 OUS) UPDATED: 1128 affected
Manufactured in
8200 Coral Sea St NE, Saint Paul, MN, United States
Products
Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1607-2013Don't want to check this manually?
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