Pacemakers & Defibrillators recalls

493 medical device recalls in the pacemakers & defibrillators category are on file with the FDA, from 2012 to 1 Jul 2026. The leading reason is device malfunction.

Total recalls493since 2012

Last 12 months20reported

Class I13427% of total

Ongoing253latest 1 Jul 2026

Recalls per month, last 24 months

click a bar for that month

4Oct '24 7 2 1Jan '25 1 4 6Apr 5 0 0Jul 3 2 7Oct 2 0 0Jan '26 2 1 2Apr 2 3 1Jul 0 0

Severity split

Class I 134 27%Class II 354 72%Class III 5 1%

Why pacemakers & defibrillators is recalled

Companies

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)11824%
Boston Scientific6814%
Philips Electronics North America357%
Philips Medical Systems275%
Philips North America255%
Medtronic245%
Physio-Control214%
MEDLINE INDUSTRIES, LP - Northfield194%

By year

2026112%
2025316%
20245311%
20239419%
2022204%
2021255%
2020214%
2019224%
20187215%
2017367%

Ongoing pacemakers & defibrillators recalls

253 active

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled	Medline Industries	Foreign Material	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled	Medline Industries	Device Malfunction	Nationwide
6 May 2026Device	CLASS I	Pacemaker, Implantable Pulse Generator, Pacemaker recalled	Boston Scientific	Device Malfunction	MN
6 May 2026Device	CLASS I	Cardiac Resynchronization Therapy (Crt)labeled as: Valitude Crt-p EL recalled	Boston Scientific	Device Malfunction	MN

All pacemakers & defibrillators recalls, newest first

493 total

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled	Medline Industries	Foreign Material	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled	Medline Industries	Device Malfunction	Nationwide
6 May 2026Device	CLASS I	Pacemaker, Implantable Pulse Generator, Pacemaker recalled	Boston Scientific	Device Malfunction	MN
6 May 2026Device	CLASS I	Cardiac Resynchronization Therapy (Crt)labeled as: Valitude Crt-p EL recalled	Boston Scientific	Device Malfunction	MN
29 Apr 2026Device	CLASS II	Medline Kits: Newborn Admission recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026Device	CLASS II	Medline Convenience Kits containing select SKUs recalled	Medline Industries	Device Malfunction	Nationwide
18 Mar 2026Device	CLASS II	Physio Control Infant/Child Reduced Energy Defibrillator Electrodes recalled	Physio-Control	Other	Nationwide
4 Feb 2026Device	CLASS II	Medline medical procedure convenience kits labeled as recalled	Medline Industries	Device Malfunction	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.