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Cardiocommand Inc. recalls CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications

Recalled June 19, 2019 · FDA recall Z-1773-2019 · Cardiocommand

Hazard
Possible corrosion of the battery contact(s). · FDA Class III
Units
5 units
Sold at
US Nationwide distribution in the states of CT, VW, OH, IL, DE.

Description

Possible corrosion of the battery contact(s).

Product
CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia
Manufacturer(s)
Cardiocommand Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Cardiocommand Inc. recalls CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications | RecallWatchUSA