Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 901

FDA device recall Z-0392-06 · posted 2006-01-13 · Terminated

Recall details

Recalling firm

Medtronic Gastroenterology / Urology

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FFT

Quantity affected

140 catheters

Distribution

CA, CO, FL, MA, OH, PA. OUS to include Finland, Italy and Portugal

Date initiated

2005-12-09

Date posted

2006-01-13

Date terminated

2006-12-21

Location

Shoreview, MN