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Terminated

Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102 Z-033-1 Tempo V, Model 1902 Z-034-1 Tempo DR, Model 2101 Z-035-1 Tempo D, Model 2902 Z-036-1 Meta, Model 1256

FDA Recall Z-0341-03 · Posted 2002-12-18

Recalling FirmSt Jude Medical
Recall StatusTerminated
Product CodeDXY
Date Initiated2002-11-04
Date Terminated2004-12-14
Product Quantity1146

Reason for Recall

Potential loss of pacing function. Expansion of recalls Z-031-1 thru Z-036-1

Firm Action

Firm issued 'Dear Doctor' letters to following physicians which listed patient''s that the Doctor was responsible for. The letter informs of the situation regarding the potential loss of pacing function and recommends that the professional healthcare provider review and evaluate patients with the affected devices as soon as possible. Additional conditions to consider are specified for pacemaker dependent versus nondependent patients.

Root Cause

Other

Distribution Pattern

Nationwide and Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Rep., France, Germany, Italy, Netherlands, Spain, Turkey, Venezuela.

Official Source

View FDA Recall →

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

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