notyard
09-04-2008, 08:36 AM
FDA class II recall:
PRODUCT
a) Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular
Mapping Catheter- The catheter is indicated for multiple electrode
electrophysiological mapping of the cardiac structures of the heart, i.e.,
recording and stimulation only. The device is designed to obtain electro
grams in the Atrial regions of the heart, Recall # Z-1703-2008;
b) Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular
Mapping Catheter- The catheter is indicated for multiple electrode
electrophysiological mapping of the cardiac structures of the heart, i.e.,
recording and stimulation only. The device is designed to obtain electrograms
in the Atrial regions of the heart. 20 Poles, US Catalog Number D7L202515RT,
EU Catalog Number 35T2515R, Recall # Recall # Z-1704-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioSense Webster Inc., Diamond Bar, CA, by letter dated March 25, 2008.
Manufacturer: BioSense Webster, Inc., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and separation of the distal end of the catheter may occur. Also,the firm determined that when the catheter is fully deflected and the variable loop is fully contracted, it is possible that the catheter mechanism can become "locked" in position and cannot return to the un-contracted, un-deflected state. This could lead to damage to the device or limit the ability to withdraw the catheter safely.
VOLUME OF PRODUCT IN COMMERCE
14,295 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
a) Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular
Mapping Catheter- The catheter is indicated for multiple electrode
electrophysiological mapping of the cardiac structures of the heart, i.e.,
recording and stimulation only. The device is designed to obtain electro
grams in the Atrial regions of the heart, Recall # Z-1703-2008;
b) Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular
Mapping Catheter- The catheter is indicated for multiple electrode
electrophysiological mapping of the cardiac structures of the heart, i.e.,
recording and stimulation only. The device is designed to obtain electrograms
in the Atrial regions of the heart. 20 Poles, US Catalog Number D7L202515RT,
EU Catalog Number 35T2515R, Recall # Recall # Z-1704-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioSense Webster Inc., Diamond Bar, CA, by letter dated March 25, 2008.
Manufacturer: BioSense Webster, Inc., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and separation of the distal end of the catheter may occur. Also,the firm determined that when the catheter is fully deflected and the variable loop is fully contracted, it is possible that the catheter mechanism can become "locked" in position and cannot return to the un-contracted, un-deflected state. This could lead to damage to the device or limit the ability to withdraw the catheter safely.
VOLUME OF PRODUCT IN COMMERCE
14,295 units
DISTRIBUTION
Nationwide and Internationally