VITALITY HE (model T180) Implantable Cardioverter Defibrillator (ICD). Sterile EO. Guidant Corporation, Cardiac Rhythm M

FDA device recall Z-1193-06 · posted 2006-07-04 · Terminated

Recall details

Recalling firm

Guidant Corporation

Reason for recall

Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). Repetitive mechanical stress in this orientation can result in Loss of shock therapy, Loss of pacing therapy (intermittent or permanent), Loss of telemetry, Programmer warning screen upon interrogation, and beeping.

Action taken

The recall was initiated on May 15, 2006, with a press release and a letter to physicians. Physicians are asked to review the specific positioning of each device for patients implanted with affected models. This is a review of medical records to determine if the device is subpectoral. Then use of an AP radiograph on patients with a subpectoral implant to determine device orientation and if leads exit in a clockwise direction. In those cases, it''s recommended physicians advise the patient of the potential for failure, and follow-up at least once per quarter per device labeling and consider device replacement for larger muscle/active patients or for patients who regularly utilize therapy. Physicians are instructed to orient device with the serial number facing away from the ribs for future implants.

Root cause

Other

Status

Terminated

Product code

LWP

Quantity affected

54,971 devices have been distributed however this only affects those that have been implanted subpectorally with the serial number facing the ribs.

Distribution

Nationwide, US Virgin Islands, Puerto Rico and worldwide to include: Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cypr

Date initiated

2006-05-15

Date posted

2006-07-04

Date terminated

2007-01-06

Location

Saint Paul, MN