Class 3 Device Recall TAPSYSTEM Model 2A

• Date Initiated by Firm: June 24, 2019
• Create Date: July 15, 2019
• Recall Status: Terminated on April 01, 2021
• Recall Number: Z-1976-2019
• Recall Event ID: 83173
• PMA Number: P840002
• Product Classification: System, esophageal pacing - Product Code LPA
• Product: TAPSYSTEM Model 2A, REF 8002A
• Code Information: SERIAL NUMBERS: 2197A, 2196A, 2198A, 2199A, 2200A, and 2201A.
• FEI Number: 1927197
• Recalling Firm/ Manufacturer: Cardiocommand Inc.; 4920 W Cypress St Ste 110; Tampa FL 33607-3837
• For Additional Information Contact: Gerlad Maass; 813-289-5555
• Manufacturer Reason for Recall: There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.
• FDA Determined Cause: Process control
• Action: On June 24, the firm plans to send URGENT MEDICAL DEVICE letters to six consignees that will advise them of the issue, request that they either return their device or perform an ON/OFF switch verification procedure, and to return the attached REPLY FORM.
• Quantity in Commerce: 6 units
• Distribution: United States - AR, NM, PA, TX, and WA.
• 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