FDA Medical Device Recalls (openFDA)
Cardiocommand Inc.: 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
- Recall number
- Z-1773-2019
- 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
- Status
- Terminated
- Initiated
- 2019-05-10
- Posted
- not on file
- Terminated
- 2021-04-12
- Reason
- Possible corrosion of the battery contact(s).
- Root cause
- Process control
- Action
- The consignees were notified by letter on 05/10/2019. The notice requested the return of the unit.
- Quantity
- 5 units
- Distribution
- US Nationwide distribution in the states of CT, VW, OH, IL, DE.
- Lot, serial or model codes
- Serial Numbers: 8059, 8060, 8022, 8063, 8211
- 510(k) numbers
- not on file
- PMA numbers
- ["P860008"]
- Product code
- LPA
- Firm FEI
- 1927197
- Firm city
- Tampa
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28