FDA Medical Device Recalls (openFDA)
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 number
- Z-1617-2008
- Recalling firm
- Boston Scientific Corp
- 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.
- Status
- Terminated
- Initiated
- 2008-02-14
- Posted
- 2008-08-30
- Terminated
- 2011-01-08
- Reason
- Package sterile barrier may be breached, compromising sterility.
- Root cause
- 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
- 827 units total
- Distribution
- Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
- Lot, serial or model codes
- Model Numbers M004EPT63030 (Lot#: 0011058480, 0011118994); M004EPT6303N40 (Lot# 0011106106); and M004EPT6304K20 (Lot# 0011058482)
- 510(k) numbers
- not on file
- PMA numbers
- ["P920047"]
- Product code
- DRF
- Firm FEI
- 3001236349
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28