| Class 2 Device Recall LASSO 2515 Variable Circular Mapping Catheter | |
Date Initiated by Firm | March 25, 2008 |
Date Posted | August 25, 2008 |
Recall Status1 |
Terminated 3 on May 03, 2012 |
Recall Number | Z-1704-2008 |
Recall Event ID |
47522 |
510(K)Number | K031161 |
Product Classification |
Circular Mapping Catheter - Product Code DRF
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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 |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Biosense Webster Inc 3333 S Diamond Canyon Rd Diamond Bar CA 91765-4701
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For Additional Information Contact | Diana M. Thorson 909-839-8604 |
Manufacturer 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 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DRF
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