Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 27, 2022
Merlin PCS 3650 programmer Model 3330 software
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchroniz…
St. Jude Medical, Cardiac Rhythm Management Division recalled Merlin PCS 3650 programmer Model 3330 software - a moderate-severity action.
Merlin PCS 3650 programmer Model 3330 software was recalled by St. Jude Medical, Cardiac Rhythm Management Division in April 27, 2022. Reason: Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decreme…. Check the official notice for the remedy. Verify recall #Z-0964-2022 with the FDA Devices before acting.
The recall
St. Jude Medical, Cardiac Rhythm Management Division issued this moderate-severity FDA Devices recall-Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decreme….
- Moderate
- severity level
- 30K units
- affected scope
- Class II
- classification
- April 27, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0964-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0964-2022) was formally reported on April 27, 2022, with the manufacturer initiating the action on March 10, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. 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 30,069 devices with software.
The documented reason for this recall is: Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the… Distribution data in the federal record shows the product reached: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, …. 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
30,069 devices with software
Related Recalls
6
6 from same agency
Product description
Merlin PCS 3650 programmer Model 3330 software
Reason for recall
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0964-2022 |
| Date reported | April 27, 2022 |
| Date initiated | March 10, 2022 |
| Recalling firm | St. Jude Medical, Cardiac Rhythm Management Division |
| Firm location | Sylmar, CA |
| Affected scope | 30,069 devices with software |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, … |
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-0964-2022) 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 programmer Model 3330 software. Recalled by St. Jude Medical, Cardiac Rhythm Management Division. Units affected: 30,069 devices with software.
Why was this product recalled? ▼
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2022. Severity: Moderate. Recall number: Z-0964-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY. The countries of Argentina, Australia, AUSTRIA, Bahrain, Bangladesh, BELGIUM, Brazil, Bulgaria, Canada, Chile, COLOMBIA, COSTA RICA, Cyprus, Czech republic, DENMARK, ECUADOR, Egypt, Estonia, Faroe Islands, FINLAND, FRANCE, French Guiana, French Polynesia, GERMANY, Greece, Greenland, Guadeloupe, HUNGARY, Iceland, India, IRELAND, ITALY, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Liechtenstein, LITHUANIA, Luxembourg, Malaysia, Malta, Martinque, Mayotte, MEXICO, Nepal, NETHERLANDS, New Caledonia, New Zealand, NORWAY, Oman, Pakistan, Palestine, POLAND, PORTUGAL, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Srilanka, SWEDEN, SWITZERLAND, Thailand, UAE, and UNITED KINGDOM..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0964-2022) 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
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 27, 2022. 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.