RecallRadar

FDA Device recall Z-1773-2019

CardioCommand, Inc

On 2019-06-19 the FDA classified a Class III recall of CardioCommand, Inc by Cardiocommand, citing possible corrosion of the battery contact(s).

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1773-2019
ClassificationClass III
Statusterminated
Initiated2019-05-10
Published2019-06-19
Last updated2026-09-13 11:55 UTC
CompanyCardiocommand
DistributionUS

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

Reason

Possible corrosion of the battery contact(s).

Identifiers

code_infoSerial Numbers: 8059, 8060, 8022, 8063, 8211

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1773-2019%22

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