FDAClass IIJanuary 24, 2018

ALTRUA 2 EL DR Pacemaker recall

ALTRUA 2 EL DR Pacemaker

Why was ALTRUA 2 EL DR 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 S722

Product
ALTRUA 2 EL DR 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)
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