Recall Z-0789-2014— Codman & Shurtleff, Inc.
Class I · Terminated
Class I FDA medical device recall by Codman & Shurtleff, Inc., initiated 2013-10-11, terminated 2015-07-28. FDA's recall record names no specific 510(k) clearance for this event. Product: TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.. Reason: Incorrect instructions for use (IFU)..
- Recalling firm
- Codman & Shurtleff, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-10-11
- Terminated
- 2015-07-28
- Firm location
- Raynham, MA, United States
Product description
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.
Reason for recall
Incorrect instructions for use (IFU).
Data sourced from openFDA. This site is unofficial and independent of the FDA.