Circular Mapping Catheter-Biosense Webster LASSO 2515… recallZ-1704-2008 · Biosense Webster Inc · initiated Mar 25, 2008
Terminated All recalls posted in August 2008
Is my device affected?
- 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.
- 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.
- 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
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1704-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 25, 2008
- Posted by the FDA
- Aug 25, 2008
- Recalling firm
- Biosense Webster Inc
- Quantity
- 14,295 units for both products
- Product code
- DRF
- FDA submissions
- K031161
- 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
Product description
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
Code information (models, lots, serial numbers)
All lots
Other devices under the same FDA submission
1 device cleared under K031161 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Lasso D7L102515RTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 47522).
- Z-1703-2008 · TerminatedCircular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardi…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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