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CARTO 3 Systems, Product Code M-4800-01 recallZ-1230-2012 · Biosense Webster, Inc. · initiated Feb 9, 2012

Terminated All recalls posted in March 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biosense Webster, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Some CARTO 3 Systems may get radio frequency interference through certain interconnected cable configurations resulting in jumping or disappearing catheter icon and/or error messages during ablation.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Three Urgent Customer Notification recall communications were initiated 2/9/12 with Biosense forwarding the notification to customers with affected backplane cards (electrophysiology lab managers, a notification for customers with affected back plane cards (risk managers), and a notification for customers with affected backplane cards and smarttouch module along with customer acknowledgement forms. The letters provides the customers with an explanation of the problem identified and steps to take in the event that the issue is observed. If the steps provided do not resolve the issue, customers are to contact their Biosense Webster representative. A Biosense Webster representative will contact customers to schedule an appointment for the replacement of the Backplane card. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. If customers have questions, they can contact their BWI representative.

Recall details

Recall number
Z-1230-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 9, 2012
Posted by the FDA
Mar 20, 2012
Recalling firm
Biosense Webster, Inc.
Quantity
134 units total (32 units in US)
Product code
DQK
FDA submissions
K090017, K093455, K103746, K112007
Distribution
Worldwide Distribution -- US, Japan, China, Ireland, Germany, Italy, Slovenia, Indonesia, Poland, Spain, United Kingdom, Switzerland, Belgium, and Canada.

Product description

CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.

Code information (models, lots, serial numbers)

Catalog # FG-5400-00  Serial numbers: 11996, 11998, 11999, 12002, 12026, 12031, 12040, 12046, 12047, 12051, 12052, 12057, 12061, 12062, 12063, 12065, 12066, 12067, 12069, 12070, 12075, 12077, 12078, 12086, 12087, 12088, 12089, 12094, 12096, 12098, 12099, and 12111.

Other devices under the same FDA submission

6 devices cleared under K090017, K093455, K103746, K112007 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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