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.
This recall has been terminated (originally issued August 30, 2008).
- Company
- Boston Scientific Corp
- Recall Initiated
- February 14, 2008
- Posted
- August 30, 2008
- Terminated
- January 8, 2011
- Recall Number
- Z-1617-2008
- Quantity
- 827 units total
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Package sterile barrier may be breached, compromising sterility.
Distribution
Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
Lot / Code Info
Model Numbers M004EPT63030 (Lot#: 0011058480, 0011118994); M004EPT6303N40 (Lot# 0011106106); and M004EPT6304K20 (Lot# 0011058482)
Root Cause
Nonconforming Material/Component
Action Taken
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.
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