Recall Z-3258-2018— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2018-09-10, terminated 2019-11-04. FDA's recall record names no specific 510(k) clearance for this event. Product: VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker). Reason: 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-10
- Terminated
- 2019-11-04
- Firm location
- Saint Paul, MN, United States
Product description
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.