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U.S. Department of Health and Human Services

Class 3 Device Recall Transesophageal Cardiac Pacing and Recording System

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  Class 3 Device Recall Transesophageal Cardiac Pacing and Recording System see related information
Date Initiated by Firm May 10, 2019
Create Date June 12, 2019
Recall Status1 Terminated 3 on April 12, 2021
Recall Number Z-1773-2019
Recall Event ID 82803
PMA Number P860008 
Product Classification System, esophageal pacing - Product Code LPA
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
Code Information Serial Numbers: 8059, 8060, 8022, 8063, 8211
Recalling Firm/
Manufacturer		 Cardiocommand Inc.
4920 W Cypress St Ste 110
Tampa FL 33607-3837
For Additional Information Contact Gerald F. Maas
813-289-5555 Ext. 225
Manufacturer Reason
for Recall		 Possible corrosion of the battery contact(s).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LPA and Original Applicant = CARDIO COMMAND
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