Boston Scientific SteeroCath-T Ablation Catheter. This… recallZ-1617-2008 · Boston Scientific Corp · initiated Feb 14, 2008
Terminated All recalls posted in August 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Package sterile barrier may be breached, compromising sterility.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-1617-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 14, 2008
- Posted by the FDA
- Aug 30, 2008
- Recalling firm
- Boston Scientific Corp
- Quantity
- 827 units total
- Product code
- DRF
- FDA submissions
- P920047
- Distribution
- Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
Product description
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 (models, lots, serial numbers)
Model Numbers M004EPT63030 (Lot#: 0011058480, 0011118994); M004EPT6303N40 (Lot# 0011106106); and M004EPT6304K20 (Lot# 0011058482)
Other devices under the same FDA submission
15 devices cleared under P920047 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Blazer® II HTD M0045031TH0Boston Scientific Corporation · Cardiac ablation percutaneous catheter14 reports
- IntellaNav™ ST M004R5031TH0Boston Scientific Corporation · Cardiac ablation percutaneous catheter10 reports
- Blazer® II HTD M0045031THK20Boston Scientific Corporation · Cardiac ablation percutaneous catheter7 reports
- IntellaNav™ ST M004R5031THK20Boston Scientific Corporation · Cardiac ablation percutaneous catheter5 reports
- Blazer® II M0045031T0Boston Scientific Corporation · Cardiac ablation percutaneous catheter4 reports
- Blazer® II M0045031TK20Boston Scientific Corporation · Cardiac ablation percutaneous catheter3 reports
- Blazer Prime® HTD M004P5031TH0Boston Scientific Corporation · Cardiac ablation percutaneous catheter3 reports
- Blazer® II M0045031TK10Boston Scientific Corporation · Cardiac ablation percutaneous catheter2 reports
- Blazer Prime® HTD M004P5031THN40Boston Scientific Corporation · Cardiac ablation percutaneous catheter2 reports
- Blazer® II HTD M0045031THN40Boston Scientific Corporation · Cardiac ablation percutaneous catheter1 report
- Blazer® II M0045031TL0Boston Scientific Corporation · Cardiac ablation percutaneous catheter1 report
- Blazer® II M0045770TN40Boston Scientific Corporation · Cardiac ablation percutaneous catheter1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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