CLASS II Device recall · Reported 22 Apr 2020 · FDA Enforcement Report

Merlin PCS recalled by Abbott

Abbott is recalling Merlin PCS 3650, distributed in 39 states. The recall was initiated on 28 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Version: 24.6.1 Model: 3650, GTIN: 05414734500661 Model: 3330, GTIN: 05414734509725 For affected serial number of programmers see Attachment B.1 Programmers For models of ICDs interrogated by affected programmers see Attachment B.2 Devices.

Quantity recalledSoftware Version 24.6.1 installed into 4733 programmers

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1700-2020
FDA event ID: 85275
Recalling firm: Abbott, Sylmar, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 Feb 2020
FDA classified: 10 Apr 2020
Reported: 22 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

28 Feb 2020	Recall initiated by company
10 Apr 2020	Classified by FDA	+42 days
22 Apr 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Alaska Arkansas Arizona California Colorado District of Columbia Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Missouri

Questions about this recall

Why was it recalled?

Which lots are affected?

Software Version: 24.6.1 Model: 3650, GTIN: 05414734500661 Model: 3330, GTIN: 05414734509725 For affected serial number of programmers see Attachment B.1 Programmers For models of ICDs interrogated by affected programmers see Attachment B.2 Devices.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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