Guidant Initiates Voluntary Physician Advisory on Certain Pacemakers

These failure modes may result in one or more of the followingdevice behaviors:

-- Intermittent or permanent loss of pacing output without warning

-- Intermittent or permanent loss of telemetry

-- Appearance of a reset warning message upon interrogation

The clinical behaviors associated with these failure modes canresult in serious health complications. There have been no reporteddeaths resulting from these failure modes. Loss of pacing outputassociated with these failure modes has resulted in syncope as well aspresyncope requiring hospitalization.

For the first failure mode, as of September 6, 2005, Guidant hasconfirmed thirty-six (36) failures out of 49,500 implanted devices(0.073%). Seven (7) of these devices exhibited no output during theimplant procedures. For devices successfully implanted, the majorityof failures occurred early in life, with a mean implant time of seven(7) months. This failure mode demonstrates a failure rate thatdecreases with implant time. No failures have been reported beyondtwenty-two (22) months of service. Guidant has received three (3)reports of syncope, and six (6) reports of bradycardia or heart blockassociated with this failure mode which required emergencyhospitalization. One device was determined to have failed briefly andresumed functioning with no indication to the physician detectableduring routine follow-up.

Guidant's modeling based on field experience and statisticalanalysis, predicts the failure rate for the active device populationof 41,000 to be between 0.017% to 0.037% over the remaining devicelifetime, or approximately seven (7) to fifteen (15) additionalfailures. An estimated 24,000 are active in the United States. Rootcause has been identified as foreign material within a crystal timingcomponent. The supplier of the crystal timing component used in thissubset has eliminated foreign material within the crystal chamber, andno such failures have been observed in any devices shipped after March12, 2004.

The United States Food and Drug Administration (FDA) hasdetermined this communication action to be a recall. Physicians shouldconsider the projected low and declining failure rate in addition tothe unique needs of individual patients in their medical decisionsregarding patient management. Guidant recommends normal devicemonitoring, as per device labeling. As always, Guidant advisespatients to seek medical attention immediately if they experiencesyncope or lightheadedness.

As of September 6, 2005, sixteen (16) failures associated with asecond failure mode have been confirmed out of 341,000 INSIGNIA andNEXUS devices distributed worldwide (0.0047%). For all sixteendevices, a "no output" condition was exhibited at the implantprocedure or pre-implant testing. Guidant has received one (1) reportof a pacemaker-dependent patient experiencing syncope and resuscitatedcardiac arrest that occurred in association with loss of pacing outputduring an elective pulse generator replacement procedure. Root causeanalysis is ongoing; a specific root cause for this observation hasnot yet been determined. An estimated 145,000 of these devices areactive in the United States.

The United States Food and Drug Administration (FDA) may determinethis communication action to be a recall. Guidant recommends verifyingpacemaker operation in the packaging prior to the implant procedure.Devices exhibiting intermittent or permanent loss of output and/ortelemetry should not be implanted. Physicians should consider both thevery low occurrence rate and that no failures have been observed aftersuccessful confirmation of pacing at implant, in addition to theunique needs of individual patients, in their medical decisionsregarding patient management.

The following model numbers are affected by this communication(a):
Guidant Pacemakers Guidant Intermedics Pacemakers
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Device Family Model Numbers Device Family Model Numbers
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INSIGNIA Entra SSI 0484, 0485 NEXUS Entra SSI 1325, 1326
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INSIGNIA Entra DDD 0985, 0986 NEXUS Entra DDD 1425, 1426
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INSIGNIA Entra SR 1195, 1198 NEXUS Entra SR 1395, 1398
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INSIGNIA Entra DR 1294, 1295, 1296 NEXUS Entra DR 1466, 1494, 1495
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INSIGNIA Ultra SR 1190 NEXUS Ultra SR 1390
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INSIGNIA Ultra DR 1290, 1291 NEXUS Ultra DR 1490, 1491
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INSIGNIA Plus SR 1194 NEXUS Plus SR 1394
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INSIGNIA Plus DR 1297, 1298 NEXUS Plus DR 1467, 1468
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INSIGNIA AVT SSI 482 NEXUS AVT SSI 1328
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INSIGNIA AVT VDD 882 NEXUS AVT VDD 1428
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INSIGNIA AVT DDD 982 NEXUS AVT DDD 1432
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INSIGNIA AVT SR 1192 NEXUS AVT SR 1392
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INSIGNIA AVT DR 1292 NEXUS AVT DR 1492
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(a) Not all models are available in all geographies.

Additional information about this potential issue is available forphysicians and patients at 1-866-GUIDANT (1-866-484-3268) (24/7) andhttp://www.guidant.com/physician_communications/.

This release includes forward-looking statements concerning thecourse of developments with respect to the affected products. Thesestatements are based on assumptions about many important factors,including continuing developments with respect to adverse event rates,regulatory agency actions, and other factors identified on Exhibit 99to the company's most recent 10-Q. Actual results may differmaterially. The company does not undertake to update itsforward-looking statements.