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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 Recall
RF Ablation System Foot Switch
see related information
Date Posted January 14, 2009
Recall Status1 Open
Recall Number Z-0858-2009
Recall Event ID 50483
Premarket Approval
PMA Numbers
P020025 P927004 P980003
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, California 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LPB and Applicant = BOSTON SCIENTIFIC
PMAs with Product Code = LPB and Applicant = BOSTON SCIENTIFIC CORP.
PMAs with Product Code = LPB and Applicant = BOSTON SCIENTIFIC CORPORATION
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