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VITALITY DR+ Implantable Cardioverter Defibrillator (ICD)… recallZ-1513-2008 · Boston Scientific CRM Corp · initiated Jan 7, 2008

Terminated All recalls posted in August 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific CRM Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1513-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 7, 2008
Posted by the FDA
Aug 21, 2008
Recalling firm
Boston Scientific CRM Corp
Quantity
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.)
Product code
LWP
FDA submissions
P960040
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 description

VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872

Code information (models, lots, serial numbers)

Devices that are implanted subpectorally with the serial number facing the ribs. Implant orientation is not reported to Boston Scientific CRM.

Other devices under the same FDA submission

45 devices cleared under P960040 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 46297).

Sources and updates

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