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

Recall date

May 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1773-2019

FDA classification

Class III

Brand / firm

Cardiocommand Inc.

Sold / distributed

US Nationwide distribution in the states of CT, VW, OH, IL, DE.

Why it was recalled

Possible corrosion of the battery contact(s).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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