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U.S. Department of Health and Human Services

Class 2 Device Recall SteeroCathT Ablation Catheter

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  Class 2 Device Recall SteeroCathT Ablation Catheter see related information
Date Initiated by Firm February 14, 2008
Date Posted August 30, 2008
Recall Status1 Terminated 3 on January 08, 2011
Recall Number Z-1617-2008
Recall Event ID 47388
PMA Number P920047 
Product Classification Cardiac Catheter - Product Code DRF
Product Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product in not indicated for use as an ablation catheters indicated for treatment of atrial flutter or for atrial fibrillation.
Code Information Model Numbers M004EPT63030 (Lot#: 0011058480, 0011118994); M004EPT6303N40 (Lot# 0011106106); and M004EPT6304K20 (Lot# 0011058482)
Recalling Firm/
Manufacturer		 Boston Scientific Corp
150 Baytech Drive
San Jose CA 95134
For Additional Information Contact
408-935-3400
Manufacturer Reason
for Recall		 Package sterile barrier may be breached, compromising sterility.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Recall initiated on Feb. 14, 2008, via Urgent Medical Device Recall notification being sent to consignees, along with a reply verification tracking form. If you have questions or need a copy of the recall notification, contact Deborah J. Springer at 1-408-935-4944 or springed@bsci.com.
Quantity in Commerce 827 units total
Distribution Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
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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