Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Recalled by Medtronic Inc. Cardiac Rhythm Disease Management Due to Medtronic recently identified an issue with a subset...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc. Cardiac Rhythm Disease Management directly.
Affected 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.
Quantity: 1912 (159 USA & 1137 OUS) UPDATED: 1128 affected
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 24 states: AL, AR, CA, FL, GA, IL, IN, KS, KY, LA, ME, MI, MN, MO, NE, NY, OH, OK, PA, SC, TN, TX, VA, WI
About Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Inc. Cardiac Rhythm Disease Management has 23 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report