St. Jude Medical, Cardiac Rhythm Management Division Merlin PCS 3650 programmer Model 3330 software Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Merlin PCS 3650 programmer Model 3330 software
Brand
St. Jude Medical, Cardiac Rhythm Management Division
Lot Codes / Batch Numbers
Software Model 3330 v26.0.1 rev 1 or earlier, UDI/DI 05414734509725
Products Sold
Software Model 3330 v26.0.1 rev 1 or earlier; UDI/DI 05414734509725
St. Jude Medical, Cardiac Rhythm Management Division is recalling Merlin PCS 3650 programmer Model 3330 software due to There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
Recommended Action
Per FDA guidance
On June 16, 2022 Abbott issued a "Medical Device Correction" via: XXXX to affected consignees. The customer notification ask consignees to take the following action: 1. Prophylactic device replacement is not recommended, as device functionality, actual longevity, and ERI indicator are not impacted (device functionality remains normal and within specifications). 2. Routine follow-up should remain as per local standard of care and clinical protocol, and ERI should continue to serve as an indicator of the need for device replacement scheduling. 3. Please direct any questions about device longevity to Abbott Technical Support at 1-800-722-3774 (U.S.). 4.Upon programmer software / remote monitoring software update, the improved longevity estimate will be displayed at the patient s next interrogation. Please note that until programmers are updated, a difference in longevity estimates between programmers and remote monitoring (Merlin.net) may be observed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026