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

Recall Z-1284-2015 — TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use in cardiac electrop

U.S. FDA — Device Enforcement · United States · 2014-11-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1284-2015
Date of alert: 2014-11-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: St Jude Medical
Product category: device
Product type: Devices

Reported risk: A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.

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.

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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