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Terminated

CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. Quantities Distributed by model are as follows: CONTAK RENEWAL TR model H120 = 359, model H125 = 235; TR2 model H140 = 613, model H145 = 390.

FDA Recall Z-1298-06 · Posted 2006-09-28

Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeNKE
Date Initiated2006-06-24
Date Terminated2008-03-02
Product Quantity1,597

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 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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