Boston Scientific Corp 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Model Numbers M004EPT63030 (Lot#: 0011058480, 0011118994), M004EPT6303N40 (Lot# 0011106106), and M004EPT6304K20 (Lot# 0011058482)
Products Sold
Model Numbers M004EPT63030 (Lot#: 0011058480, 0011118994); M004EPT6303N40 (Lot# 0011106106); and M004EPT6304K20 (Lot# 0011058482)
Boston Scientific Corp is recalling Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indication due to Package sterile barrier may be breached, compromising sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Package sterile barrier may be breached, compromising sterility.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026