Medtronic Gastroenterology Urology 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Medtronic Gastroenterology Urology
Lot Codes / Batch Numbers
Lot numbers 571, 606, 695, 754, 952, 945, 1024, 1066
Products Sold
Lot numbers 571, 606, 695, 754, 952, 945, 1024, 1066
Medtronic Gastroenterology Urology is recalling Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. due to Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the Digitrapper pH rec. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, MA, OH, PA
Page updated: Jan 10, 2026