Open, Classified

GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)

FDA Recall Z-0308-03 · Posted None

Recall StatusOpen, Classified

Date Initiated2002-11-14

Product Quantity2539 devices

Reason for Recall

Extended charge times prior to defibrillation shock.

Firm 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 Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.