CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary

FDA device recall Z-0218-2024 · posted 2023-11-03 · Open, Classified

Recall details

Recalling firm

St. Jude Medical

Reason for recall

Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.

Action taken

Abbott notified clinics on about 10/04/2023 via hand delivery of IMPORTANT MEDCIAL DEVICE CORRECTION letter. Clinics were instructed to continue following the IFU and also the supplemental guidance in the letter to continue taking readings as your Health Care Professional has recommended, inspect the Power Connector Plug for damage prior to taking your next reading, if you suspect or identify damage to the power connector plug or any other issues, call Abbott Technical Support, and after the initial inspection, Abbott requests that each Patient Electronics System power connector plug is inspected monthly for damage. Clinics were also notified that patients would be notified of the issue using the addresses listed in the Merlin.net" Patient Care Network; please ensure all patient addresses are up to date. Patients were notified on about 10/18/2023, via IMPORTANT MEDCIAL DEVICE CORRECTION letter. Patients were instructed to continue to take readings as your Health Care Professional has recommended, inspect the power connecter plug for damage prior to taking your next reading, if you suspect or identify damage to the power connector plug contact Abbott Technical Support at 1-844-MYCMEMS (1-844-692-6367) Monday-Friday: 8am-8pm ET, and Abbott requests that each Patient Electronics System power connector plug is inspected monthly for damage.

Root cause

Device Design

Status

Open, Classified

Product code

MOM

Quantity affected

36,153 units

Distribution

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, KUWAIT, NETHERLANDS, PORTUGAL, SAU

Date initiated

2023-10-04

Date posted

2023-11-03

Location

Atlanta, GA