Reported Mar 15, 2023 · Ongoing
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary…
St. Jude Medical
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 · 387 Technology Cir Nw Ste 500 · Atlanta, GA · 30313-2424
Is this the product you have?
- CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
- Lot codes and dates
- UDI/DI 05414734509237
- Serial numbers
4,070 of 4,070 codes
H24Y92H24YB8H24YJYH24YSKH24YY9H24YZGH24Z3BH24Z8SH24ZEEH24ZF7H24ZHHH24ZMNH24ZTVH24ZVPH24ZWLK24YFWK25YCEK25YEYK25YKNK25Z4KK26WLCK26WN6K26WT4K26WVEK26WY3K26WZAK26X2NK26X48K26X53K26X6AK26X7HK26X84K26X97K26XEQK26XGSK26XHPK26XJVK26XKWK26XLBK26XMGK26XN9K26XPXK26XQUK26XVHK26XWAK26XY4K27VK3K27VNUK27VP2K27VQ9K27VUVK27VWPK27W2WK27W5BK27W8CK27W9FK27WA4K27WBDK27WNHK27WQL
- Amount recalled
- 36875 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
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 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.