Home › Device types › FFT
Electrode, Ph, Stomach
FDA product code FFT · Class 1 · Gastroenterology, Urology
109
Registered devices
12,972
Adverse events
11
Recalls
49
510(k) clearances
Devices with this code
Versaflex — Given Imaging, Inc.Versaflex — Given Imaging, Inc.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.2 channel pH antimony, 15 cm spacing, 6.4 Fr — Medical Measurement Systems B.V.Versaflex — Given Imaging, Inc.Bravo — Given Imaging, Inc.Versaflex — Given Imaging, Inc.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Versaflex — Given Imaging, Inc.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Versaflex — Given Imaging, Inc.Versaflex — Given Imaging, Inc.Versaflex — Given Imaging, Inc.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.2 channel pH antimony, 5 cm spacing, 6.4 Fr — Medical Measurement Systems B.V.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Versaflex — Given Imaging, Inc.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.alpHaONE — Chongqing Jinshan Science & Technology (Group) Co., LtdBravo — Given Imaging, Inc.Versaflex — Given Imaging, Inc.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Versaflex — Given Imaging, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-06 | Given Imaging Ltd. | Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstructi |
| 2025-06-03 | Given Imaging Ltd. | It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may p |
| 2021-02-26 | Covidien Llc | 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 |
| 2021-02-26 | Covidien Llc | 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 |
| 2016-04-15 | Covidien LLC | Potential of an allergic reaction in a patient with nickel sensitivity. |
| 2016-04-15 | Covidien LLC | Potential of an allergic reaction in a patient with nickel sensitivity. |
| 2007-12-03 | Medtronic Neuromodulation | Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall. |
| 2006-01-25 | Medtronic Gastroenterology / Urology | 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 patien |
| 2005-12-09 | Medtronic Gastroenterology / Urology | 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. Me |
| 2003-09-24 | Sandhill Scientific, Inc | Pouch containing pediatric probes was labeled as containing adult probes. |
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