Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A. Sizes: 4 CM in length, REF (240) 27782 a. 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.

FDA Recall Z-1134-2009 · Posted 2009-03-27

Recalling FirmMedtronic Neurosurgery
Recall StatusTerminated
Product CodeJXG
Date Initiated2009-02-12
Date Terminated2010-11-08
Product Quantity3048 of all units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- USA, Ireland, and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983331MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102Medtronic PS Medical · 1998-12-16K951258PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KITPudenz-Schulte Medical Research Corp. · 1995-09-18K874498CSF-VENTRICULOSTOMY RESERVOIRPudenz-Schulte Medical Research Corp. · 1988-02-11K792007CSF-VENTRICULAR CATHETER, STANDARD DESPudenz-Schulte Medical Research Corp. · 1980-01-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑