Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic Slimline Catheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Medtronic Slimline Catheter see related information
Date Initiated by Firm December 09, 2005
Date Posted January 13, 2006
Recall Status1 Terminated 3 on December 21, 2006
Recall Number Z-0392-06
Recall Event ID 34246
Product Classification Electrode, Ph, Stomach - Product Code FFT
Product Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141. Distributed by / Medtronic Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA
Code Information Lot numbers 571, 606, 695, 754, 952, 945, 1024, 1066
Recalling Firm/
Manufacturer		 Medtronic Gastroenterology / Urology
4000 Lexington Ave N
Shoreview MN 55126-2917
Manufacturer Reason
for Recall		 Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the Digitrapper pH recorder. Medtronic has determined that patient safety is not compromised, but catheter function may be affected and damage may result to the Digitrapper pH recorder.
FDA Determined
Cause 2		 Other
Action Letters will be sent to distributors, end-users and Medtronic Field Personnel. The end-user will be asked to return via fax a confirmation/customer receipt. Letters identify the affected catalog number and lot numbers. Customers are asked to return affected product and will receive replacement product.
Quantity in Commerce 140 catheters
Distribution CA, CO, FL, MA, OH, PA. OUS to include Finland, Italy and Portugal
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.
-
-