Z-1976-2019Class III

TAPSYSTEM Model 2A, REF 8002A

Name: Z-1976-2019 TAPSYSTEM Model 2A, REF 8002A
Creator: Cardiocommand Inc.
Published: 2019-06-24
License: https://open.fda.gov/license/

Cardiocommand Inc. / initiated 2019-06-24 / Terminated / root cause: manufacturing process

FDA source

Cardiocommand Inc. began a recall of TAPSYSTEM Model 2A, REF 8002A on 2019-06-24. FDA classified it as Class III and gives the reason as "There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1976-2019
Classification: Class III
Status: Terminated
Initiated: 2019-06-24
Posted: 2019-07-15
Terminated: 2021-04-01
Recalling firm: Cardiocommand Inc.
Product: TAPSYSTEM Model 2A, REF 8002A
Product code: LPA System, Esophageal Pacing
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: SERIAL NUMBERS: 2197A, 2196A, 2198A, 2199A, 2200A, and 2201A.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1976-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1976-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-15

Product code LPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)