Quick Facts at a Glance
- Recall Date
- May 12, 2026
- Hazard Level
- HIGH
- Brand
- Abbott Medical
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Abbott Medical
- Model numbers
- Programmer Model 3650, Software Model 3330, GTIN 05414734509725, Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 12, 2026
Reported by FDA DEVICE
June 17, 2026
RecallRadar source check
June 23, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott Medical or your healthcare provider for instructions. Notification method: Letter
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Full Description
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software. Reason: Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.. Classification: Class II. Quantity: 11182 programs. Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: Not provided yet
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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