St Jude Medical Recalls TactiSys Quartz Pack for Configuration Update

Plain-English summary

St Jude Medical is recalling 89 units of the TactiSys Quartz Pack (PN-004 400). This medical device is used for percutaneous catheter radiofrequency ablation of atrial cardiac arrhythmias and allows for the visualization of contact force between the TactiCath quartz catheter tip and the heart wall.

The recall is being conducted because a configuration update is required on the TactiSys system to appropriately recognize all TactiCath catheters. The affected units were distributed nationwide in the United States, specifically in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, LA, MD, MA, MI, MN, MS, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, and WA.

Healthcare facilities and users should contact St Jude Medical for instructions on how to perform the necessary configuration update. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product

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

Manufacturer

St Jude Medical

Category

Medical Device — Cardiac Electrophysiology

Hazard

• software-error
• device-malfunction

Affected units

89

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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