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Terminated

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

FDA Recall Z-1773-2019 · Posted None

Recalling FirmCardiocommand Inc.
Recall StatusTerminated
Product CodeLPA
Date Initiated2019-05-10
Date Terminated2021-04-12
Product Quantity5 units

Reason for Recall

Possible corrosion of the battery contact(s).

Firm Action

The consignees were notified by letter on 05/10/2019. The notice requested the return of the unit.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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