Recall Z-1125-2009 ยท JXG Shunt, Central Nervous System And Components
Medtronic Neurosurgery
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782K. Sizes:5.5CM in length, REF (240) 27782K. 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.
| Date | Mar 27, 2009 (initiated Feb 12, 2009) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 3048 of all units |
| Distribution | Worldwide Distribution -- USA, Ireland, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K792007 | CSF-VENTRICULAR CATHETER, STANDARD DES Pudenz-Schulte Medical Research Corp., Jan 16, 1980 |
| K874498 | CSF-VENTRICULOSTOMY RESERVOIR Pudenz-Schulte Medical Research Corp., Feb 11, 1988 |
| K951258 | PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT Pudenz-Schulte Medical Research Corp., Sep 18, 1995 |
| K983331 | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 Medtronic PS Medical, Dec 16, 1998 |