Z-1704-2008

Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is...

Name: Z-1704-2008 Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is...
Creator: Biosense Webster Inc
Published: 2008-03-25
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2008-03-25 / Terminated / root cause: design

FDA source

Biosense Webster Inc began a recall of Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological... on 2008-03-25. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1704-2008
Status: Terminated
Initiated: 2008-03-25
Posted: 2008-08-25
Terminated: 2012-05-03
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
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
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
Root cause tag: design
FDA 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 in commerce: 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
Product codes and lots: All lots

Product code DRF

K031161Class IIVariable Lasso 2515 Circular Mapping CatheterBiosense Webster, Inc. / cleared 2003-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)