Z-1514-2008

VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual...

Name: Z-1514-2008 VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual...
Creator: Boston Scientific CRM Corp
Published: 2008-01-07
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-01-07 / Terminated / root cause: design

FDA source

Boston Scientific CRM Corp began a recall of VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber on 2008-01-07. The reason FDA records is "Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1514-2008
Status: Terminated
Initiated: 2008-01-07
Posted: 2008-08-21
Terminated: 2008-12-30
Recalling firm: Boston Scientific Corporation
Product: VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
Product code: LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Reason for recall: Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. This update identifies additional VITALITY ICD
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Information Update to May 2006 Product Advisory, dated January 04, 2008, was sent to implanting physicians and physicians following implanted devices beginning Monday, January 07, 2008. The letter described a malfunction that can occur when the ICD is implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. The physicians were asked to review records to determine if an affected device was implanted subpectorally. An AP radiograph should be done to determine specific device orientation for subpectoral implants. If a subpectoral implant is in a susceptible orientation, consider repositioning or replacement for physically active patients who regularly need device therapy. Follow patients with susceptible devices at 3-month intervals.
Quantity in commerce: BSC CRM estimates that the number of devices implanted in a susceptible orientation is likely less than 1% of the total active implants 25,000 (w.w.)
Distribution: Nationwide and Worldwide: Bolivia, Panama, Iran, Saudi Arabia, Kuwait, United Arab Rep., Austria, Belgium, Cyrus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, India, Australia, New Zealand, Malaysia, Singapore, Hong Kong, China, Israel, Turkey, Thailand, and Canada.
Product codes and lots: Devices that are implanted subpectorally with the serial number facing the ribs. Implant orientation is not reported to Boston Scientific CRM.

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)