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CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10'… recallZ-0884-2011 · Biosense Webster, Inc. · initiated Oct 5, 2010

Terminated All recalls posted in January 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

When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor.

FDA root cause category: Device Design

What the company is doing

Biosense Webster issued an Urgent Field Safety Notice letter dated October 5, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to return the affected cable, accompanied by the attached Return Authorization form. For questions regarding this recall call Biosense Webster at 909 839-8874.

Recall details

Recall number
Z-0884-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 5, 2010
Posted by the FDA
Jan 7, 2011
Recalling firm
Biosense Webster, Inc.
Quantity
1692
Product code
DSA
FDA submissions
K090017
Distribution
Worldwide Distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, MA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, and WV, and the countries of Belgium, China, Israel, Japan, Singapore, and Thailand.

Product description

CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT This product provides a signal interface between a Biosense Webster electrophysiology catheter and the appropriate equipment. This cable may be re-used subject to established cleaning and sterilization restrictions

Code information (models, lots, serial numbers)

Part Number: D-1286-18; Catalog Number CR3410CT

Other devices under the same FDA submission

6 devices cleared under K090017 — 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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