Visionist X4 Crt-p recall
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Why was Visionist X4 Crt-p 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
VISIONIST X4 (CRT-P) model U228
- Product
- VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
- Recalling firm
- Boston Scientific Corporation
- Distribution
- AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY
- Recall date
- October 3, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)