FDA Device Intelligence
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System, Esophageal Pacing

FDA product code LPA · Class 3 · Unknown

17
Registered devices
0
Adverse events
5
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2019-06-24Cardiocommand Inc.There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.
2019-05-10Cardiocommand Inc.Possible corrosion of the battery contact(s).
2010-10-25Cardiocommand Inc.CardioCommand, Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the
2010-10-25Cardiocommand Inc.CardioCommand, Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the
2003-10-27Cardiocommand Inc.The device may exhibit spurious heart rate increase during esophageal atrial pacing during simultaneous adjacent use of electrosurgical coagulation devices.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.