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Terminated

Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330

FDA Recall Z-1351-2020 · Posted None

Recalling FirmSt Jude Medical, Cardiac Rhythm Management Division
Recall StatusTerminated
Product CodeNVZ
Date Initiated2020-01-22
Date Terminated2020-12-17
Product Quantity256

Reason for Recall

Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.

Firm Action

Starting on 01/22/20, Important Medical Device Correction notices were hand delivered by the recalling firm's sales representatives. Physicians were informed that the recalling firm developed a software patch for programmers which restores wireless RF communication capability in affected devices. Device explant is not required for the update. The recalling firm will assist in updating programmer software and restoring wireless RF communication for affected devices. Correction notices recommend working with firm representatives to help correct affected devices during the patient's next regularly scheduled visit. Physicians were asked to complete and return the Acknowledgement Forms and to retain the correction notice. Customers with additional questions were encouraged to call Technical Support at 1-800-722-3774.

Root Cause

Other

Distribution Pattern

U.S.: WV, MS, TX, DE, OH, AZ, MI, NC, KY, WA, NY, CA, IN, MO, MD, NJ, FL, PA, OK. O.U.S.: United Kingdom, Turkey, Sweden, Spain, Portugal, Poland, Philippines, Pakistan, Norway, New Zealand, Netherlands, Japan, Italy, Hong Kong, Greece, Germany, France, Finland, Denmark, Canada, Belgium, Austria, Australia

Official Source

View FDA Recall →

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

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