Reported Apr 27, 2022 · Ongoing
Merlin PCS 3650 programmer Model 3330 software
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 3650 programmer Model 3330 software
- Lot codes and dates
- Model 3330 software Versionv25.X
- X UDI05414734509725
- System Affected Serial Numbers
5,419 of 5,419 codes
113391134111344113451134611347113481135011351113521135311355113581135911360113621136411368113721137311374113751137911380113821138511386113871148911491114921149411496114971149811499115011150211505115071150811509115101151211513115161151711518115221152411530115341153611537115421154511550115521155411555
- Amount recalled
- 30,069 devices with software
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
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.