Z-0955-05

VITALITY AVT, model A135 and model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular...

Name: Z-0955-05 VITALITY AVT, model A135 and model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular...
Creator: Boston Scientific CRM Corp
Published: 2005-06-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-06-17 / Terminated

FDA source

Boston Scientific CRM Corp began a recall of VITALITY AVT, model A135 and model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide... on 2005-06-17. The reason FDA records is "The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0955-05
Status: Terminated
Initiated: 2005-06-17
Posted: 2005-06-30
Terminated: 2008-03-02
Recalling firm: Boston Scientific Corporation
Product: VITALITY AVT, model A135 and model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
Product code: LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Reason for recall: The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.
FDA root cause: Other
Action: Firm issued a Dr. Doctor letter dated 06/17/05. Letter informs physicians of the issue, clinical implications, recommendations and action taken by the firm.
Quantity in commerce: 22,575 devices (19,446 implanted world wide)
Distribution: worldwide. To the US and OUS countries to include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Turkey, US - Virgin Islands and United Kingdom.
Product codes and lots: all serial numbers

Product code LWP

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)