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U.S. Department of Health and Human Services

Class 2 Device Recall RF Ablation System Foot Switch

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  Class 2 Device Recall RF Ablation System Foot Switch see related information
Date Initiated by Firm November 25, 2008
Date Posted January 14, 2009
Recall Status1 Terminated 3 on April 26, 2011
Recall Number Z-0858-2009
Recall Event ID 50483
PMA Number P9270047 
Product Classification Cardiac Ablation Percutaneous Catheter - Product Code LPB
Product RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Manufactured by Altech Corporation, Flemmington NJ and distributed by Boston Scientific Corporation, San Jose, CA, catalog numbers/UPN numbers 21840/M004 218400.

Indicated for use in cardiac ablation procedures.
Code Information M004 218400, Serial numbers starting in 0430200, 0530100, 0606100, 0610000, 0620200, 0623700, 0626500, 0629900, 0634800, and ending in 001-405.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
150 Baytech Dr
San Jose CA 95134-2302
Manufacturer Reason
for Recall		 Product malfunction may result in delivery of energy without depressing the foot switch that controls delivery.
FDA Determined
Cause 2		 Process control
Action Recall initiated on November 25, 2008. Urgent Company Initiated Medical Device Recall - Immediate Action Required letters, dated 11/26/2008, were sent to consignees via Federal Express and included return and reply forms for consignees to respond. The letters asked that further distribution or use of any foot switch affected by this recall be ceased immediately. Attached to the letter was a document entitled "Instructions for Determining Affected Product," which provided instructions and serial numbers for determining if customers have product affected by this recall. In addition, a document entitled "Recall Instructions" was also attached. Affected product should be segregated and returned to Boston Scientific in accordance to the "Recall Instructions," and the Reply and Verification Tracking Form should be completed and returned. Customers will receive replacement product for all recalled product returned to Boston Scientific. Local Sales Reps should be contacted in regards to any questions customers may have pertaining to this recall.
Quantity in Commerce 322 units
Distribution Worldwide Distribution --- including USA and countries of France, Great Britain, Saudi Arabia, Spain, Canada, Portugal, Germany, Italy, Australia, Russia, Netherlands, Ireland, Libya.
Total Product Life Cycle TPLC Device Report
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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