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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide

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  Class 1 Device Recall Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide see related information
Date Initiated by Firm February 12, 2009
Date Posted March 27, 2009
Recall Status1 Terminated 3 on November 08, 2010
Recall Number Z-1128-2009
Recall Event ID 51287
510(K)Number K792007  K874498  K951258  K983331  
Product Classification Central Nervous System Shunt and Components - Product Code JXG
Product Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782G. Sizes 10cm in length, REF (240) 27782G. 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 2		 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 and Original Applicant = MEDTRONIC PS MEDICAL
510(K)s with Product Code = JXG and Original Applicant = PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
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