Medtronic Inc. Cardiac Rhythm Managment Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271
Brand
Medtronic Inc. Cardiac Rhythm Managment
Lot Codes / Batch Numbers
Manufacturing Dates from May 1997 to August 1998, and Use Before Dates from November 1998 to February 2000.
Products Sold
Manufacturing Dates from May 1997 to August 1998; and Use Before Dates from November 1998 to February 2000.
Medtronic Inc. Cardiac Rhythm Managment is recalling Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271 due to Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected char. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices.
Recommended Action
Per FDA guidance
A letter, dated April 2004, was sent on April 5, 2004 to physicians following patients who had the defibrillators implanted. The letter gave recommendations to physicians for selective replacement of some of the implanted devices and for avoiding the problem. Physicians are being visited by sales representatives to verify notification.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026