Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 1, 2019
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It 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 c
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Abbott recalled St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product U… - a moderate-severity action.
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product U… was recalled by Abbott in May 1, 2019. Reason: The device is unable to pair with the mobile app due to the device incorrectly determining the certificate ha…. Check the official notice for the remedy. Verify recall #Z-1220-2019 with the FDA Devices before acting.
The recall
Abbott issued this moderate-severity FDA Devices recall-The device is unable to pair with the mobile app due to the device incorrectly determining the certificate ha….
- Moderate
- severity level
- 32 units
- affected scope
- Class II
- classification
- May 1, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1220-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1220-2019) was formally reported on May 1, 2019, with the manufacturer initiating the action on November 19, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott is listed as the recalling firm, operating out of Sylmar, CA. Federal records list the affected scope as 32 devices.
The documented reason for this recall is: The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, LA, MA, MI, MO, NE, NH, NJ, NY, TN, TX, and WI.. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
32 devices
Related Recalls
6
6 from same agency
Product description
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It 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
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1220-2019 |
| Date reported | May 1, 2019 |
| Date initiated | November 19, 2018 |
| Recalling firm | Abbott |
| Firm location | Sylmar, CA |
| Affected scope | 32 devices |
| Distribution | US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, LA, MA, MI, MO, NE, NH, NJ, NY, TN, TX, and WI. |
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-1220-2019) 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? ▼
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It 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 Abbott. Units affected: 32 devices.
Why was this product recalled? ▼
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2019. Severity: Moderate. Recall number: Z-1220-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, LA, MA, MI, MO, NE, NH, NJ, NY, TN, TX, and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1220-2019) 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.
Nearby Recalls in This Category
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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 May 1, 2019. 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 August 2026.