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

Merlin 2 PCS MER37000 programmer Model MER3400 software — recall Z-1496-2022

U.S. FDA — Device Enforcement · United States · 2022-06-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1496-2022
Date of alert
2022-06-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
St. Jude Medical, Cardiac Rhythm Management Division
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05415067037121
Reported risk: The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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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.