VISIONIST CRT-P Pacemaker recall
VISIONIST CRT-P Pacemaker
Why was VISIONIST CRT-P Pacemaker recalled?
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Model U225 and Model 226
- Product
- VISIONIST CRT-P Pacemaker
- Recalling firm
- Boston Scientific Corporation
- Quantity
- N/A
- Distribution
- AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide
- Recall date
- January 24, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)