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

Percepta Quad CRT-P MRI SureScan, REF W4TR04 — recall Z-2415-2018

U.S. FDA — Device Enforcement · United States · 2018-06-21 · Class II

As described by U.S. FDA — Device Enforcement: Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequen

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2415-2018
Date of alert
2018-06-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US Nationwide
Barcode (EAN/GTIN)
00643169735705
Reported risk: Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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