FDA Medical Device Recalls (openFDA)
Biosense Webster Inc: 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 number
- Z-1704-2008
- Recalling firm
- Biosense Webster Inc
- 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
- Status
- Terminated
- Initiated
- 2008-03-25
- Posted
- 2008-08-25
- Terminated
- 2012-05-03
- 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 sep
- Root cause
- Device Design
- Action
- 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.
- 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, Turkey, United Kingdom
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K031161"]
- PMA numbers
- not on file
- Product code
- DRF
- Firm FEI
- 3002951223
- Firm city
- Diamond Bar
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28