Class 1 Device Recall Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide

• Date Initiated by Firm: February 12, 2009
• Date Posted: March 27, 2009
• Recall Status: Terminated on November 08, 2010
• Recall Number: Z-1152-2009
• Recall Event ID: 51287
• 510(K)Number: K792007 K874498 K951258 K983331
• Product Classification: Central Nervous System Shunt and Components - Product Code JXG
• Product: Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27802J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized.
• Code Information: All Lots
• Recalling Firm/ Manufacturer: Medtronic Neurosurgery; 125-B Cremona Dr; Goleta CA 93117
• For Additional Information Contact: Chuck Grothaus; 805-968-1546
• Manufacturer Reason for Recall: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
• FDA Determined Cause: Device Design
• Action: An Urgent - Medical Device Recall notification was sent on February 13,2009 to the attention of risk managers, advising them to cease use of the Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782 ( all versions and all lot numbers), the Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27802 ( all versions and all lot numbers), and the Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27708 ( all version and all lot numbers). Each customer is to cease the use of the listed product and any unused unit needs to be returned to Medtronic. Further, each account is required to account for product used/implanted and to advise surgeons of the recall information. Each account will recieved an individualized Customer Product Reconciliation Form provided by their Medtronic Sales Representative for determining the status of any product shipped to them.
• Quantity in Commerce: 3048 of all units
• Distribution: Worldwide Distribution -- USA, Ireland, and Australia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JXG; 510(K)s with Product Code = JXG