Z-2329-2018Class II

Merlin PCS programmer (Model # 3650), Software (Model # 3330)

Name: Z-2329-2018 Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Creator: St Jude Medical Inc.
Published: 2018-04-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-04-16 / Terminated / root cause: software

FDA source

St Jude Medical Inc. began a recall of Merlin PCS programmer (Model # 3650), Software (Model # 3330) on 2018-04-16. FDA classified it as Class II and gives the reason as "The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2329-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-16
Posted: 2018-06-29
Terminated: 2024-03-08
Recalling firm: Abbott Medical
Product: Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Product code: OSR Pacemaker/Icd/Crt Non-Implanted Components
Reason for recall: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Root cause tag: software
FDA root cause: Software design
Action: On 04/16/2018, Important Medical Device Advisory notifications were mailed via overnight service to U.S. physicians and hospitals notifying customers of the availability of the programmer software update and associated ICD/CRT-D firmware update. Advisory notifications were mailed to customers outside the U.S. on different dates depending on geography and local regulatory requirements. Prophylactic replacement of affected devices is not recommended. The firm recommends firmware upgrades for all eligible patients at the next regularly scheduled visit or when appropriate depending on the preferences of the patient and physician. For devices not eligible for the cybersecurity firmware update the firm recommends a discussion of the risks of cybersecurity vulnerabilities and proven benefits of remote monitoring with patients at their next regularly scheduled visit. RF communication may be permanently disabled in devices not eligible for firmware updates during an in-clinic device interrogation with a programmer that has received the software update. Customers with questions about the firmware update can call the customer technical support hotline at 1-800-436-5056.
Quantity in commerce: 71651
Distribution: U.S. Nationwide distribution
Product codes and lots: Software Versions: 24.1.1 rev1 (US), 23.1.2 rev 1 (OUS), 23.1.3 (Japan), and 23.1.4 rev 1 (Canada)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2329-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2318-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28
Z-2319-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28
Z-2320-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28
Z-2321-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28
Z-2322-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28
Z-2323-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28
Z-2324-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28
Z-2325-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28
Z-2326-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28
Z-2327-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28
Z-2328-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28
Z-2329-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28

Product code OSR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)