20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
Reported: April 3, 2013 Initiated: March 5, 2013 #Z-1023-2013
Product Description
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
Reason for Recall
Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
Details
- Recalling Firm
- Biosense Webster, Inc.
- Units Affected
- 54 units
- Distribution
- Worldwide Distribution - USA (Nationwide) including the states of: DE, NL, CH, FR, GB, DK.
- Location
- Irwindale, CA
Frequently Asked Questions
What product was recalled? ▼
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.. Recalled by Biosense Webster, Inc.. Units affected: 54 units.
Why was this product recalled? ▼
Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2013. Severity: Moderate. Recall number: Z-1023-2013.
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