Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Discovery Multiprogrammable Pacemaker, DDDR Model 1273

FDA Recall Z-0883-03 · Posted 2003-05-29

Recalling FirmGuidant Corp-Cpi Division
Recall StatusTerminated
Product CodeDXY
Date Initiated2003-05-06
Date Terminated2005-11-18

Reason for Recall

In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.

Firm Action

An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.

Root Cause

Other

Distribution Pattern

Nationwide in the United States and worldwide.

Official Source

View FDA Recall →

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

↑