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U.S. Department of Health and Human Services

Class 3 Device Recall TAPSYSTEM Model 2A

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  Class 3 Device Recall TAPSYSTEM Model 2A see related information
Date Initiated by Firm June 24, 2019
Create Date July 15, 2019
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = CARDIOCOMMAND, INC.
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