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Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3… recallZ-1140-2009 · Medtronic Neurosurgery · initiated Feb 12, 2009

Terminated All recalls posted in March 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neurosurgery or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1140-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 12, 2009
Posted by the FDA
Mar 27, 2009
Recalling firm
Medtronic Neurosurgery
Quantity
3048 of all units
Product code
JXG
FDA submissions
K792007, K874498, K951258, K983331
Distribution
Worldwide Distribution -- USA, Ireland, and Australia.

Product description

Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. 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 (models, lots, serial numbers)

All Lots

Other devices under the same FDA submission

28 devices cleared under K792007, K874498, K951258, K983331 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 51287).

Sources and updates

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