Recall Z-1704-2008
Biosense Webster Inc · initiated March 25, 2008
Product
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
Codes / lots: All lots
Reason for recall
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 sep
FDA-determined cause: Device Design
Action taken
A letter entitled, "Urgent Safety Field Notice" dated March 25, 2008, and certification form were sent to all customers and Johnson & Johnson affiliates who purchased the product in the past year as of March 25, 2008, due to the expiration date. For customers in the US, two letters and forms were sent out - one addressed to the EP/Cardiology Lab and a second to the Risk Management Office. If you have questions or have not received a letter contact Customer Service at 1-800-729-9010.
Details
- Recall number
- Z-1704-2008
- Initiated
- March 25, 2008
- Posted by FDA
- August 25, 2008
- Terminated
- May 3, 2012
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Quantity
- 14,295 units for both products
- Distribution
- Nationwide and Worldwide to: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary , Iran, Ireland, Isra¿¿l, Italy, Japan, Lithuania, Luxembourg, Mexico, Middle East, Netherlands, Norway, Panama, Poland, Portugal, Russia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan…
- Recalling firm
- Biosense Webster Inc, Diamond Bar, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1703-2008 | Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping…This recall was initiated after the firm received several complaints reporting issues with deflection. The… | 03/25/2008Terminated |