Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 22, 2020
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programme…
Abbott recalled Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient C… - a moderate-severity action.
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient C… was recalled by Abbott in April 22, 2020. Reason: Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value…. Check the official notice for the remedy. Verify recall #Z-1700-2020 with the FDA Devices before acting.
The recall
Abbott issued this moderate-severity FDA Devices recall-Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value….
- Moderate
- severity level
- Class II
- classification
- April 22, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1700-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1700-2020) was formally reported on April 22, 2020, with the manufacturer initiating the action on February 28, 2020. 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 Software Version 24.6.1 installed into 4733 programmers.
The documented reason for this recall is: Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be … Distribution data in the federal record shows the product reached: U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no …. 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
Software Version 24.6.1 installed into 4733 programmers
Related Recalls
6
3 from same agency
Product description
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
Reason for recall
Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1700-2020 |
| Date reported | April 22, 2020 |
| Date initiated | February 28, 2020 |
| Recalling firm | Abbott |
| Firm location | Sylmar, CA |
| Affected scope | Software Version 24.6.1 installed into 4733 programmers |
| Distribution | U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no OUS consignees assoc… |
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-1700-2020) 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 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.. Recalled by Abbott. Units affected: Software Version 24.6.1 installed into 4733 programmers.
Why was this product recalled? ▼
Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2020. Severity: Moderate. Recall number: Z-1700-2020.
Where was the recalled product distributed? ▼
Distribution: U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no OUS consignees associated to ICDs that were interrogated from January 22, 2020 to February 6, 2020..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1700-2020) 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 April 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.