CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary

FDA device recall Z-1221-2023 · posted 2023-03-03 · Open, Classified

Recall details

Recalling firm

St. Jude Medical

Reason for recall

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).

Action taken

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

Root cause

Device Design

Status

Open, Classified

Product code

MOM

Quantity affected

1,905 units

Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherl

Date initiated

2023-02-07

Date posted

2023-03-03

Location

Atlanta, GA