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Terminated

Guidant INSIGNIA I AVT --family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: VDD (model 1428), DDD (model 1432), SR (model 1392) and DR (model 1492). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant.-- The NEXUS I AVT pacemakers are multiprogrammable pacemakers from Intermedics. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Quantities Distributed by model are as follows: INSIGNIA AVT SSI model 482 = 303; VDD model 882 = 789; DDD model 982 = 656; SR model 1192 = 988; DR model 1292 = 1,408. NEXUS AVT VDD model 1428 = 67; SR model 1392 = 19; DR model 1492 = 39. ****The following devices are not available in the US. *****

FDA Recall Z-1296-06 · Posted 2006-09-28

Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeLWP
Date Initiated2006-06-24
Date Terminated2008-03-02
Product Quantity4,269

Reason for Recall

Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion or loss of pacing output without warning in the affected devices

Firm Action

A Press Release was issued on 06/26/06. An Urgent Medical Device Safety Information & Corrective Action letter, dated 06/23/06 was delivered to physicians describing preliminary information before Guidant has completed its own investigation and finalized patient care recommendations. Non-implanted inventory is being retrieved from hospital shelves and Guidant Represenatatives. Physicians are to perform an in-clinic follow-up exam as soon as possible with patients implanted with affected devices.

Root Cause

Other

Distribution Pattern

Worldwide- USA and Antigua Barbuda, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Micronesia, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela

Official Source

View FDA Recall →

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

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