Recall Z-1617-2008
Boston Scientific Corp · initiated February 14, 2008
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.
Codes / lots: Model Numbers M004EPT63030 (Lot#: 0011058480, 0011118994); M004EPT6303N40 (Lot# 0011106106); and M004EPT6304K20 (Lot# 0011058482)
Reason for recall
Package sterile barrier may be breached, compromising sterility.
FDA-determined 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.
Details
- Recall number
- Z-1617-2008
- Initiated
- February 14, 2008
- Posted by FDA
- August 30, 2008
- Terminated
- January 8, 2011
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Quantity
- 827 units total
- Distribution
- Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
- Recalling firm
- Boston Scientific Corp, San Jose, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1618-2008 | Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific…Package sterile barrier may be breached, compromising sterility. | 02/14/2008Terminated |