FDA Recall
Open, Classified
GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)
Recall: Z-0308-03
·
Initiated November 14, 2002
Recall
- Recall Number
- Z-0308-03
- Event Number
- 25041
- Status
- Open, Classified
- Initiated
- November 14, 2002
- Address
- 7000 Central Ave N.E., Medtronic, Inc/Rice Creek Facil, Fridley, 55432
Description
GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)
Reason
Extended charge times prior to defibrillation shock.
Action
An 'Important Patient Management Information' letter, dated November 14, 2002, was sent to physicians following patients who had the defibrillators implanted and this gave recommendations to physicians to prevent the problem.
Distribution
The devices have been distributed nationwide in the United States and worldwide. 2,151 units have been distributed in the United States, and 387 units have been distributed worldwide outside the U.S.
Quantity
2539 devices