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Terminated

Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Quantities Distributed by model are as follows: VENTAK PRIZM VR model 1860 = 67; DR model 1861 = 108.

FDA Recall Z-1297-06 · Posted 2006-09-28

Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeKRG
Date Initiated2006-06-24
Date Terminated2008-03-02
Product Quantity175

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 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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