FDA Medical Device Recalls (openFDA)
Abbott: 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.
- Recall number
- Z-1700-2020
- Recalling firm
- Abbott
- Product
- 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.
- Status
- Terminated
- Initiated
- 2020-02-28
- Posted
- not on file
- Terminated
- 2024-04-18
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.).
- Quantity
- 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 associated to ICDs that were interrogated from January 22, 2020 to February 6, 2020.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P030035S177","P910023S422","P030054S373"]
- Product code
- NIK
- Firm FEI
- 2017865
- Firm city
- Sylmar
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28