Class 2 Device Recall Zinetics Reference pH Catheter

• Date Initiated by Firm: January 25, 2006
• Date Posted: May 03, 2006
• Recall Status: Terminated on December 21, 2006
• Recall Number: Z-0830-06
• Recall Event ID: 34535
• Product Classification: Electrode, Ph, Stomach - Product Code FFT
• Product: Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA.
• Code Information: Lot 0001491
• FEI Number: 1000135098
• Recalling Firm/ Manufacturer: Medtronic Gastroenterology / Urology; 4000 Lexington Ave N; Shoreview MN 55126-2917
• Manufacturer Reason for Recall: Lot 0001491 has a manufacturing defect in the sensor spacing. Sensors have been placed 5 cm apart instead of 15 cm apart. Medtronic has determined that patient safety is not compromised. Clinicians however should review and reassess the results of any patient studies for which catheters from lot 0001491 were used.
• FDA Determined Cause: Other
• Action: An Urgent Recall letter was issued to all affected customers 1/25/2006. This letter described the issue and listed what actions customers were to take to return affected product.
• Quantity in Commerce: 25 individual catheters
• Distribution: within US only: MI, PA, TX
• Total Product Life Cycle: TPLC 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.