Recall Z-0620-2016— Boston Scientific Corporation

Name: FDA recall Z-0620-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-10

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2015-12-10, terminated 2016-03-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary. Reason: The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-12-10
Terminated: 2016-03-08
Firm location: Saint Paul, MN, United States

Product description

Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary

Reason for recall

The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.

Data sourced from openFDA. This site is unofficial and independent of the FDA.