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

Recall Z-2412-2018 — Percepta CRT-P MRI SureScan, REF W1TR01 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, sequential

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

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2412-2018
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
Barcode (EAN/GTIN): 00643169735637

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.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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