PROPONENT Pacemaker
Reported: October 3, 2018 Initiated: September 10, 2018 #Z-3256-2018
Product Description
PROPONENT Pacemaker
Reason for Recall
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.
Details
- 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
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
PROPONENT Pacemaker. Recalled by Boston Scientific Corporation.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2018. Severity: Moderate. Recall number: Z-3256-2018.
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