Class III — Cardiocommand Inc.
| Recalling firm | CARDIOCOMMAND, INC. |
|---|---|
| Registered facility | CARDIOCOMMAND, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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 differenti… |
| Quantity | 5 units |
| Distribution | US Nationwide distribution in the states of CT, VW, OH, IL, DE. |
| Initiated | 2019-05-10 |
| Classified | 2019-06-12 |
| Terminated | 2021-04-12 |
| Recall number | Z-1773-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Cardiocommand Inc. (Z-1773-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82803/
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