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Terminated

Maximo II CRT D284TRK, for ventricular pacing and defibrillation.

FDA Recall Z-0667-2009 · Posted 2009-01-28

Recalling FirmMedtronic Inc. Cardiac Rhythm Managment
Recall StatusTerminated
Product CodeNIK
Date Initiated2008-07-25
Date Terminated2011-05-07
Product Quantity313

Reason for Recall

Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. Although the algorithm is operating correctly, it is not accessible to the clinician for reprogramm

Firm Action

A Medtronic Inc. letter dated July 30, 2008 was sent to Physicians. The letter described the product and problem. The letter advised to contact Technical Services for specific questions regarding the care of patients or how to program the Maximo II devices. The letter instructed to collect and hold all non-implanted Maximo II devices and that a Medtronic Representative will contact the doctor to make arrangements to update the programmer 2090.

Root Cause

Process design

Distribution Pattern

No US distribution. OUS to include: AUSTRIA, DENMARK, FINLAND, GERMANY, ITALY, SPAIN, SWEDEN, UK, GREECE, HONG KONG, INDIA, JORDAN, and SAUDI ARABIA.

Official Source

View FDA Recall →

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

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