FDA issues notification of recall of Guidant defibrillators and Guidant
issues new warnings
26 June 2005
The US Food and Drug Administration issued a national recall of certain
Guidant implantable defibrillators and cardiac resynchronisation therapy
defibrillators on 17 June.
The FDA said the devices can develop an internal short circuit without
warning, resulting in failure to deliver a shock when needed. The PRIZM 2
and RENEWAL devices are subject to different failures, resulting in the
devices' inability to deliver an electrical shock during episodes of
arrhythmia — which could lead to a serious, life-threatening event for a
patient. There have been two deaths reported to the FDA suspected of being
caused by these devices. About 29,000 devices are affected.
The devices affected by this notification are:
- PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002.
- CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004.
- CONTAK RENEWAL 2, Model H155, manufactured on or before August 26,
The FDA notification can be found at:
According to StarNewsOnline, Guidant did not tell doctors for over three
years about the electrical flaw in one model, the Ventak Prizm 2 DR Model
1861, that it has recalled. It also kept selling older versions of it after
developing a version not prone to short-circuiting.
About 17,000 people, 13,900 of them in the United States, are implanted
with the affected Prizm 2 DR devices. Another 11,900 people, 6,700 of them
in the USA, have the affected Renewal devices.
Further problems with Guidant defibrillators were announced this week.
Guidant Corporation issued a press release on 24 June saying that it is
"voluntarily advising physicians about important safety information
regarding certain devices". The devices affected are:
- CONTAK RENEWAL 3 and 4.
- RENEWAL 3 and 4 AVT.
- RENEWAL RF.
Guidant says that it has determined that the devices are subject to a
component failure that may limit available therapy. "We have determined that
a magnetic switch in these devices may become stuck in the closed position,
which in some cases inhibits the device’s ability to treat ventricular or
atrial tachyarrhythmias and can accelerate battery depletion. Four
occurrences have been confirmed out of approximately 46,000 devices; a fifth
occurrence is suspected but cannot be confirmed. In the four occurrences in
which the device was implanted, patients and/or physicians were alerted to
the condition by audible device tones that signalled the magnetic switch was
closed. These four occurrences have resulted in device replacement. One
occurrence occurred prior to implant. To date, there have been no patient
injuries beyond device replacement."
The press release from Guidant can be found at:
These problems will not be welcome news for Johnson & Johnson, which
agreed in December to buy Guidant for $25.4 billion.