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Versaflex
Given Imaging, Inc. · Model FGS-9000-20 · UDI-DI 04260167484136
FFT
Prescription
10
510(k) clearances
12,853
Adverse events (9 deaths)
10
Recalls
8
Facilities
Description
Disposable pH / Impedance Catheter, Dual pH Sensor, 25cm, 8 Impedance Rings, LPR ZNID25+8R
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 prevent the capsule f |
| 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 intervention to remo |
| 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 intervention to remo |
| 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 patient safety is not comp |
| 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. Medtronic has determin |
| 2003-09-24 | Sandhill Scientific, Inc | Pouch containing pediatric probes was labeled as containing adult probes. |
| 2003-01-08 | Sandhill Scientific, Inc | Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.