Z-0702-03

Tachos DR - Atrial TX Implantable Cardioverter Defibrillators

Name: Z-0702-03 Tachos DR - Atrial TX Implantable Cardioverter Defibrillators
Creator: Biotronik Inc
Published: 2003-02-21
License: https://open.fda.gov/license/

BIOTRONIK AG / initiated 2003-02-21 / Terminated

FDA source

Biotronik Inc began a recall of Tachos DR - Atrial TX Implantable Cardioverter Defibrillators on 2003-02-21. The reason FDA records is "Potential for battery to delivery less than full amount of energy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0702-03
Status: Terminated
Initiated: 2003-02-21
Posted: 2003-04-01
Terminated: 2003-09-08
Recalling firm: BIOTRONIK AG
Product: Tachos DR - Atrial TX Implantable Cardioverter Defibrillators
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: Potential for battery to delivery less than full amount of energy
FDA root cause: Other
Action: The firm issued an 'URGENT - VOLUNTARY MEDICAL DEVICE' recall letter dated 2/21/03 to the physicians. This letter explains the issue and recommends scheduling an immediate follow-up with the patients. The letter describes conditions under which the patient should be monitored on a weekly basis (versus every 3 months), and under which conditions the device should be explanted.
Quantity in commerce: 49 devices (45 still implanted)
Distribution: The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm.
Product codes and lots: Model No. 122 499 Serial Nos. 78010961, 78012035, 78012076, 78012077, 78012083, 78012090-78012092, 78012103-78012105, 78012109-78012111, 78012117-78012120, 78012122-78012125,78012127, 78012132, 78012163, 78012197, 78012236, 78012292, 78012296, 78012298-78012302, 78012352, 78012354, 78012355, 78012366, 78012369, 78012374, 78012386, 78012413, 78012415, 78012564, 78012652

Product code LWS

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)