Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Recall Z-0808-2020 · Posted None
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Recalling FirmSt Jude Medical, Cardiac Rhythm Management Division
Recall StatusTerminated
Product CodeMXC
Date Initiated2018-04-13
Date Terminated2021-02-10
Product Quantity2,906 impacted ICMs
Reason for Recall
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Firm Action
No notification was issued for the memory corruption problem.
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide. distribution. There was also government/military distribution. Countries of Canada, Aruba, Australia, Belgium, Brazil, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Luxembourg, Martinique, Netherlands, New Caledonia, New Zealand, Norway, Oman, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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