Electrode, Ph, Stomach

Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number

It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.

Given Imaging Bravo pH capsule delivery device, 5-pack.

Potential of an allergic reaction in a patient with nickel sensitivity.

Given Imaging Bravo pH capsule delivery device, 1-pack.

Potential of an allergic reaction in a patient with nickel sensitivity.

Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001. Medtronic, Inc., Minneapolis, MN 55432

Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.

Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic, In

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.

Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012

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.

ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system

Pouch containing pediatric probes was labeled as containing adult probes.

''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually.

Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.

CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in ad

The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.

BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in a

The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.