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LASSO Deflectable Circular Mapping Catheter with Auto 10… recallZ-2667-2011 · Biosense Webster, Inc. · initiated May 23, 2011

Terminated All recalls posted in June 2011

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

The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.

FDA root cause category: Pending

What the company is doing

Biosense Webster, Inc. sent a Customer Notification Letter, dated May 24, 2011, with an Acknowledgement Form and Instructions for Manually Entering the Catheter Identification in the CARTO 3 System to all US and Outside US (OUS) customers who purchased these products. For customers in the US, two letters and forms will be sent via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively. Instructions for manual entry of the catheter identification in the CARTO 3 System are being included in the communication to customers. These instructions will allow customers to input the identity of the catheter into the CARTO 3 System and be able to utilize the catheter. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. Customers were instructed to contact their BWI representative for any questions.

Recall details

Recall number
Z-2667-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 23, 2011
Posted by the FDA
Jun 27, 2011
Recalling firm
Biosense Webster, Inc.
Quantity
382 units (24 in US)
Product code
DRF
FDA submissions
K002333
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Belgium, Japan, and Singapore

Product description

LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-1220-82-S, Catalog Numbers 07L2015CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

Code information (models, lots, serial numbers)

Catalog Numbers 07L2015CT

Other devices under the same FDA submission

2 devices cleared under K002333 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 58884).

Sources and updates

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