Z-1773-2019Class III

CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 -

Name: Z-1773-2019 CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 -
Creator: Cardiocommand Inc.
Published: 2019-05-10
License: https://open.fda.gov/license/

Cardiocommand Inc. / initiated 2019-05-10 / Terminated / root cause: manufacturing process

FDA source

Cardiocommand Inc. began a recall of CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial... on 2019-05-10. FDA classified it as Class III and gives the reason as "Possible corrosion of the battery contact(s)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1773-2019
Classification: Class III
Status: Terminated
Initiated: 2019-05-10
Posted: 2019-06-12
Terminated: 2021-04-12
Recalling firm: Cardiocommand Inc.
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
Product code: LPA System, Esophageal Pacing
Reason for recall: Possible corrosion of the battery contact(s).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The consignees were notified by letter on 05/10/2019. The notice requested the return of the unit.
Quantity in commerce: 5 units
Distribution: US Nationwide distribution in the states of CT, VW, OH, IL, DE.
Product codes and lots: Serial Numbers: 8059, 8060, 8022, 8063, 8211

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1773-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1773-2019	Class III	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-12

Product code LPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)