Recall Z-1773-2019— Cardiocommand Inc.
Class III · Terminated
Class III FDA medical device recall by Cardiocommand Inc., initiated 2019-05-10, terminated 2021-04-12. FDA's recall record names no specific 510(k) clearance for this event. 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)..
- Recalling firm
- Cardiocommand Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-05-10
- Terminated
- 2021-04-12
- Firm location
- Tampa, FL, United States
Product description
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 for recall
Possible corrosion of the battery contact(s).
Data sourced from openFDA. This site is unofficial and independent of the FDA.