Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0620-2016 — Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary

U.S. FDA — Device Enforcement · United States · 2015-12-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0620-2016
Date of alert
2015-12-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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