Reported Jan 22, 2020 · Terminated
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500,…
St Jude Medical, Cardiac Rhythm Management Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St Jude Medical, Cardiac Rhythm Management Division · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. -
- Product UsageThe Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who
- experience unexplained symptoms such asdizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation
- Lot codes and dates
Merlin PCS Programmer SoftwareV24.0.1 rev 1UDI 05414734509725. Confirm Rx ICMUDI 05415067027320
- US serial numbersand 9402889. Confirm Rx ICM, UDI 05415067027320
952 of 952 codes
316178331656303169553317236331753353175336317533731753493175356317537731753783175385317539331753943175395317539931754023178901317890731789093178916317891931789213178930317893731789433178945317894631789513178954317896231789693178974317898131789953179005317902431791033179123317914931791773179199317926031794433179452317952031795333179539317954231795433179570317958331795893179595317960331796093179850317985131799213179929
- OUS serial numbersand 3261583
1,952 of 1,952 codes
315408931541003154112315413031541343154146315418331541893154198315420931542113154236315423731542503154255315426531542973154298315430431543143154319315439931544053154406315441831544193154429315443331544353154460315493631549843155011315502031550233155027315503131554273155428315543431554523155455315551231555143155518315551931555363155551315555731555633155564315556631555713155576315558931592873159292315929531593033159306
- Amount recalled
- 2,906 impacted ICMs
Where it was sold
- Nationwide
Why it was recalled
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new St Jude Medical, Cardiac Rhythm Management… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.