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CardioMEMS HF System Hospital Electronics System (HES)… recallZ-1221-2023 · St. Jude Medical · initiated Feb 7, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from St. Jude Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).

FDA root cause category: Device Design

What the company is doing

Abbott notified consignees on about 02/07/2023 via hand-delivery of the letter within the US. The letter instructed consignees to continue to follow CardioMEMS Instructions for Use (IFU). Abbott will notify patients of the emissions issue. If you suspect a CardioMEMS Electronics System has interfered with another medical device during use, report the event to Abbott Remote Care Technical Support at 1-844-MYCMEMS (692-6367) (US). Customers were also instructed to complete and return the acknowledgement and receipt form. Abbott notified patients on about 02/07/2023 via mailed letter. Customers were instructed that they could continue use of their CardioMEMS System and that their doctor has been notified of the issue as well. If there is suspicion that interference may be occurring during a sensor reading or any other quality issues, please report it to: Abbott Technical Support at 1-844-MYCMEMS (692-6367) (US); Monday-Friday: 8am-8pm EST

Recall details

Recall number
Z-1221-2023
Status
Open, Classified
Initiated by the company
Feb 7, 2023
Posted by the FDA
Mar 3, 2023
Recalling firm
St. Jude Medical
Quantity
1,905 units
Product code
MOM
FDA submissions
P100045
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK, United Arab Emirates.

Product description

CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, 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.

Code information (models, lots, serial numbers)

Show the full code information (23k characters)

UDI/DI 05415067029331, Serial Numbers: M140100179, M140100180, M140100181, M140100182, M140100183, M140100184, M140100185, M140100186, M140200187, M140200188, M140200190, M140200191, M140200193, M140200196, M140200204, M140200205, M140200213, M140200215, M140200216, M140200218, M140200220, M140200221, M140200223, M140200224, M140200226, M140200228, M140200230, M140200233, M140200234, M140200235, M140200237, M140200238, M140200240, M140200243, M140200245, M140400469, M140400470, M140400471, M140400472, M140400474, M140600522, M140600530, M140600532, M140600536, M140600537, M140600538, M140600541, M140600542, M140600543, M140600545, M140600546, M140700687, M140700688, M140700689, M140700690, M140700691, M140700692, M140700693, M140700694, M140700698, M140700699, M140700700, M140700701, M140700703, M140700705, M140700710, M140700712, M140700713, M140700714, M140700715, M140700717, M140700718, M140700721, M140700722, M140700725, M140700726, M140700799, M140700800, M140700801, M140700804, 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M140800866, M140901181, M140901183, M141201855, M141201864, M150202510, M150202513, M150402908, M150402910, M150402933, M150503406, M150503408, M150503425, M150905423, M151005977, M151005980, M151005981, M151005982, M151005984, M151005985, M151005986, M151005987, M151005991, M151005992, M151005993, M151206552, M151206557, M160307208, M160307222, M160307225, M160307231, M160307235, M160707618, M160707619, M160707621, M160707622, M160707631, M160707632, M160707633, M160707636, M161208051, M170108105, M170608276, M170608278, M170608279, M170608280, M170608281, M170608283, M170608284, M170608288, M170608291, M170608292, M170608299, M170608300, M170608304, M170608306, M170608307, M170708322, M170808330, M170808331, M170808332, M170808333, M170808334, M170808335, M170808348, M170808349, M170808350, M170808351, M171108405, M171108435, M180208513, M180308522, M180308524, M180308528, M180308530, M180308531, M180308532, M180308533, M180308534, M180408558, M180408559, M180408560, M180408561, 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Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 91610).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page