Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 22, 2020
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 unexpl
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
St Jude Medical, Cardiac Rhythm Management Division recalled Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monito… - a moderate-severity action.
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monito… was recalled by St Jude Medical, Cardiac Rhythm Management Division in January 22, 2020. Reason: Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.. Check the official notice for the remedy. Verify recall #Z-0808-2020 with the FDA Devices before acting.
The recall
St Jude Medical, Cardiac Rhythm Management Division issued this moderate-severity FDA Devices recall-Devices inappropriately displayed a low battery indicator determined to be due to memory corruption..
- Moderate
- severity level
- Class II
- classification
- January 22, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0808-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0808-2020) was formally reported on January 22, 2020, with the manufacturer initiating the action on April 13, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. St Jude Medical, Cardiac Rhythm Management Division is listed as the recalling firm, operating out of Sylmar, CA. Federal records list the affected scope as 2,906 impacted ICMs.
The documented reason for this recall is: Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide. distribution. There was also government/military distribution. Countries of Canada, Aruba, Australia, Belgium, Brazil, Colombia, Cyprus, Czech Republic, Denmark, Finland, Fran…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,906 impacted ICMs
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0808-2020 |
| Date reported | January 22, 2020 |
| Date initiated | April 13, 2018 |
| Recalling firm | St Jude Medical, Cardiac Rhythm Management Division |
| Firm location | Sylmar, CA |
| Affected scope | 2,906 impacted ICMs |
| Distribution | 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,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0808-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by St Jude Medical, Cardiac Rhythm Management Division. Units affected: 2,906 impacted ICMs.
Why was this product recalled? ▼
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2020. Severity: Moderate. Recall number: Z-0808-2020.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0808-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 22, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.