Maquet Cardiopulmonary recalls

Maquet Cardiopulmonary has 10 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 23 Sep 2026. 6 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls10since 2018

Last 12 months4reported

Class I00% of total

Ongoing6latest 23 Sep 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 10 100%Class III 0 0%

Why maquet cardiopulmonary is recalled

Device Malfunction770%
Sterility330%

Product types

Other Medical Devices550%
Heart & Vascular Devices550%

By year

2026440%
2025220%
2018440%

Ongoing maquet cardiopulmonary recalls

6 active

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), dilator set recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), Guidewire recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), Guidewire recalled	Maquet Cardiopulmonary	Sterility	Nationwide
11 Feb 2026Device	CLASS II	Bubble Sensor for 3/8" x 3/32" tubing recalled by Maquet Cardiopulmonary	Maquet Cardiopulmonary	Device Malfunction	Nationwide
6 Aug 2025Device	CLASS II	Sprinter Cart/Sprinter Cart XL Infusion Pole recalled	Maquet Cardiopulmonary	Device Malfunction	Nationwide
4 Jun 2025Device	CLASS II	Cardiohelp System HKH 8820 Wall Holder recalled	Maquet Cardiopulmonary	Device Malfunction	IL, MO

All maquet cardiopulmonary recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), dilator set recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), Guidewire recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), Guidewire recalled	Maquet Cardiopulmonary	Sterility	Nationwide
11 Feb 2026Device	CLASS II	Bubble Sensor for 3/8" x 3/32" tubing recalled by Maquet Cardiopulmonary	Maquet Cardiopulmonary	Device Malfunction	Nationwide
6 Aug 2025Device	CLASS II	Sprinter Cart/Sprinter Cart XL Infusion Pole recalled	Maquet Cardiopulmonary	Device Malfunction	Nationwide
4 Jun 2025Device	CLASS II	Cardiohelp System HKH 8820 Wall Holder recalled	Maquet Cardiopulmonary	Device Malfunction	IL, MO
20 Jun 2018Device	CLASS II	Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag	Maquet Cardiopulmonary	Device Malfunction	PR, VA
20 Jun 2018Device	CLASS II	Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag	Maquet Cardiopulmonary	Device Malfunction	PR, VA
20 Jun 2018Device	CLASS II	Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag	Maquet Cardiopulmonary	Device Malfunction	PR, VA
16 May 2018Device	CLASS II	Cardiohelp Gas Bottle Holder HKH 8880, Product recalled	Maquet Cardiopulmonary	Device Malfunction	MO

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.