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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, BioGlidesee related information
Date Initiated by FirmFebruary 12, 2009
Date PostedMarch 27, 2009
Recall Status1 Terminated 3 on November 08, 2010
Recall NumberZ-1132-2009
Recall Event ID 51287
510(K)NumberK792007 K874498 K951258 K983331 
Product Classification Central Nervous System Shunt and Components - Product Code JXG
ProductMedtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Sizes: 6 CM in length, REF (240) 27782C. 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 ContactChuck 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
ActionAn 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 Commerce3048 of all units
DistributionWorldwide Distribution -- USA, Ireland, and Australia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JXG
510(K)s with Product Code = JXG
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