Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) Recalled by Boston Scientific Corporation Due to Boston Scientific has identified a subset of active...
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 Boston Scientific Corporation directly.
Affected Products
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Why Was This Recalled?
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
Where Was This Sold?
This product was distributed to 47 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, WY
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report