St. Jude Medical recalls

St. Jude Medical has 47 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 2 Apr 2025. 10 are still ongoing. The most frequent reason is device malfunction.

Total recalls47since 2013

Last 12 months0reported

Class I715% of total

Ongoing10latest 2 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 3 0Feb 0 1 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 7 15%Class II 39 83%Class III 1 2%

Why st. jude medical is recalled

Product types

By year

202549%
202412%
2023511%
2019613%
2018511%
20171226%
201612%
201512%
201449%
2013817%

Ongoing st. jude medical recalls

10 active

Reported	Class	Recall	Company	Reason	Where
2 Apr 2025Device	CLASS II	CardioMEMS Heart Failure (HF) System that consist recalled	St. Jude Medical	Device Malfunction	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
29 Jan 2025Device	CLASS II	Merlin.net Patient Care Network recalled by St. Jude Medical	St. Jude Medical	Device Malfunction	13 states
24 Jul 2024Device	CLASS II	Agilis NxT Steerable Introducer recalled by St. Jude Medical	St. Jude Medical	Other	MN
15 Mar 2023Device	CLASS II	CardioMEMS HF System Patient Electronics System (PES) recalled	St. Jude Medical	Device Malfunction	Nationwide

All st. jude medical recalls, newest first

47 total

Reported	Class	Recall	Company	Reason	Where
2 Apr 2025Device	CLASS II	CardioMEMS Heart Failure (HF) System that consist recalled	St. Jude Medical	Device Malfunction	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
29 Jan 2025Device	CLASS II	Merlin.net Patient Care Network recalled by St. Jude Medical	St. Jude Medical	Device Malfunction	13 states
24 Jul 2024Device	CLASS II	Agilis NxT Steerable Introducer recalled by St. Jude Medical	St. Jude Medical	Other	MN
15 Mar 2023Device	CLASS II	CardioMEMS HF System Patient Electronics System (PES) recalled	St. Jude Medical	Device Malfunction	Nationwide
15 Mar 2023Device	CLASS II	CardioMEMS HF System Patient Electronics System (PES) recalled	St. Jude Medical	Device Malfunction	Nationwide
15 Mar 2023Device	CLASS II	CardioMEMS HF System Hospital Electronics System (HES) recalled	St. Jude Medical	Device Malfunction	Nationwide
15 Mar 2023Device	CLASS II	CardioMEMS HF System PA Sensor and Delivery System recalled	St. Jude Medical	Labeling Errors	Nationwide
15 Mar 2023Device	CLASS II	CardioMEMS HF System PA Sensor and Delivery System recalled	St. Jude Medical	Labeling Errors	Nationwide
14 Aug 2019Device	CLASS I	Ellipse VR recalled by St Jude Medical	St Jude Medical	Device Malfunction	Nationwide
14 Aug 2019Device	CLASS I	Ellipse DR, Tiered-therapy cardioverter/defibrillator recalled	St Jude Medical	Device Malfunction	Nationwide
14 Aug 2019Device	CLASS I	Ellipse VR, Tiered-therapy cardioverter/defibrillator recalled	St Jude Medical	Device Malfunction	Nationwide
14 Aug 2019Device	CLASS I	Ellipse DR, Tiered-therapy cardioverter/defibrillator recalled	St Jude Medical	Device Malfunction	Nationwide
14 Aug 2019Device	CLASS I	Ellipse DR recalled by St Jude Medical	St Jude Medical	Device Malfunction	Nationwide
14 Aug 2019Device	CLASS I	Ellipse VR recalled by St Jude Medical	St Jude Medical	Device Malfunction	Nationwide
19 Dec 2018Device	CLASS II	InfinityTM DBS System 8CH Directional Lead recalled by St. Jude Medical	St. Jude Medical	Other	Nationwide
11 Jul 2018Device	CLASS II	Merlin PCS Programmer recalled by St Jude Medical	St Jude Medical	Temperature Abuse	Nationwide
11 Jul 2018Device	CLASS II	Confirm Rx Insertable Cardiac Monitor, Sterile EO recalled	St Jude Medical	Temperature Abuse	Nationwide
4 Jul 2018Device	CLASS II	Merlin PCS programmer recalled by St Jude Medical	St Jude Medical	Device Malfunction	Nationwide
4 Apr 2018Device	CLASS II	Proclaim DRG Implantable Pulse Generator recalled by St. Jude Medical	St. Jude Medical	Other	TX
25 Oct 2017Device	CLASS II	PM3544 Quadra Relieve and PM3562 Quadra Allure MP These low recalled	St Jude Medical	Other	CA
25 Oct 2017Device	CLASS II	PM 1260 Assurity + These low voltage recalled by St Jude Medical	St Jude Medical	Other	CA
25 Oct 2017Device	CLASS II	Proclaim DRG Implantable Pulse Generator recalled by St. Jude Medical	St. Jude Medical	Device Malfunction	Nationwide
25 Oct 2017Device	CLASS II	Merlin PCS 3650 Programmer recalled by St Jude Medical	St Jude Medical	Device Malfunction	CA
25 Oct 2017Device	CLASS II	Pm1214 Nuance SR Rf recalled by St Jude Medical	St Jude Medical	Other	CA
25 Oct 2017Device	CLASS II	Merlin@Home recalled by St Jude Medical	St Jude Medical	Device Malfunction	CA
25 Oct 2017Device	CLASS II	Infinity 5 Implantable Pulse Generator recalled by St. Jude Medical	St. Jude Medical	Device Malfunction	Nationwide
25 Oct 2017Device	CLASS II	PM1226 Accent ST MRI SR RF and PM2222 Accent ST These low recalled	St Jude Medical	Other	CA
19 Jul 2017Device	CLASS II	Infinity 5, Implantable Pulse Generator recalled by St. Jude Medical	St. Jude Medical	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.