ALTRUA 2 SR Pacemaker
Reported: January 24, 2018 Initiated: December 7, 2017 #Z-0362-2018
Product Description
ALTRUA 2 SR Pacemaker
Reason for Recall
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).
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 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
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
ALTRUA 2 SR Pacemaker. Recalled by Boston Scientific Corporation. Units affected: N/A.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2018. Severity: Moderate. Recall number: Z-0362-2018.
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