Z-2335-2018Class II

Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device...

Name: Z-2335-2018 Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device...
Creator: St Jude Medical Inc.
Published: 2018-04-16
License: https://open.fda.gov/license/

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

FDA source

St Jude Medical Inc. began a recall of Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this... on 2018-04-16. FDA classified it as Class II and gives the reason as "The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2335-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-16
Posted: 2018-06-29
Terminated: 2021-02-04
Recalling firm: Abbott Medical
Product: Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.
Product code: MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Reason for recall: The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Abbott, sent an "URGENT MEDICAL DEVICE CORRECTION" letters dated 05/18/2018, to its consignees notifying them that updated programmer software version 24.2.x will be made available over the next several weeks and will allow physicians to detect the presence of incorrect battery indicator prior to implant. Additionally, the programmer software will provide a mechanism to resolve the incorrect display for already implanted devices. If a low battery indicator is observed, customers were advised to contact firm technical services at 1-800-722-3774 to assist in confirmation and correction of the battery indicator display.
Quantity in commerce: 0
Distribution: U.S. Nationwide Distribution: PR, MI, NJ, IL, FL, AR, PA, KY, CA, TN, IN, AL, TX, AZ, SC, OK, VA, NH, NM, WA, CO, IA, WI, NV, UT, OH, NC, MO, DE, WV, MD, OR, NE, VT, KS, MA, IA, WY, CT, GA, MS, LA, DC, LA,
Product codes and lots: Software Versions: 24.0.1 rev 1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2335-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2334-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-06-29
Z-2335-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-06-29

Product code MXC

K163407Class IIConfirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. / cleared 2017-09-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)