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Merlin recallZ-1700-2020 · Abbott · initiated Feb 28, 2020

Class II Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

On 02/28/2020, the frim sent all US consignees an "IMPORTANT MEDICAL DEVICE CORRECTION" letter via USPS three to five-day ground service. The customer notification informed customer that they had recently deployed a Patient Care System (PCS) programmer software that contained an anomaly that may result in specific programming changes not being stored in the device. The Recalling Firm explained that when using the affected programmer software to make certain programming changes, the changes may appear to have been successfully programmed but the device could remain at previously programmed settings. This issue can occur only if changes to tachycardia therapy Tilt or Waveform (monophasic/biphasic) settings are made and therapy energy value are modified from nominal using the new programmer software. The customer notification also informs customer of Patient Management Recommendations: The Recalling Firm has developed an updated programmer software version which will correct this issue. This solution does not present additional risks to patients and no intervention is needed for patients. The Recalling Firm will update the programmer software in the coming days. For any questions contact your representative or Technical Support at 1-800-722-3774 (U.S.).

Recall details

Recall number
Z-1700-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 28, 2020
Recalling firm
Abbott
Quantity
Software Version 24.6.1 installed into 4733 programmers
Product code
NIK
FDA submissions
P030035S177, P910023S422, P030054S373
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.

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.

Code information (models, lots, serial numbers)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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