Z-1139-2009

Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a...

Name: Z-1139-2009 Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a...
Creator: Medtronic Neurosurgery
Published: 2009-02-12
License: https://open.fda.gov/license/

Medtronic Neurosurgery / initiated 2009-02-12 / Terminated / root cause: design

FDA source

Medtronic Neurosurgery began a recall of Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed... on 2009-02-12. The reason FDA records is "The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1139-2009
Status: Terminated
Initiated: 2009-02-12
Posted: 2009-03-27
Terminated: 2010-11-08
Recalling firm: Medtronic Neurosurgery
Product: Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. 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.
Product code: JXG Shunt, Central Nervous System And Components
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.
Root cause tag: design
FDA root 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.
Product codes and lots: All Lots

Product code JXG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)