Datascope recalls

Datascope has 134 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 25 Mar 2026. 87 are still ongoing. 7 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls134since 2014

Last 12 months7reported

Class I3123% of total

Ongoing87latest 25 Mar 2026

Recalls per month, last 24 months

click a bar for that month

1Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 4 0 0Feb 3 0 0May 0 0 0Aug 0 0

Severity split

Class I 31 23%Class II 93 69%Class III 10 7%

Why datascope is recalled

Product types

By year

202632%
202543%
202454%
20233929%
202243%
202197%
20202015%
201986%
20183728%
201721%

Ongoing datascope recalls

87 active

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS III	Battery Charging Station recalled by Datascope	Datascope	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	CS100 IABP recalled by Datascope	Datascope	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	CS300 IABP recalled by Datascope	Datascope	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS III	Cardiosave Hybrid recalled by Datascope	Datascope	Other	Nationwide
24 Dec 2025Device	CLASS III	Cardiosave Rescue recalled by Datascope	Datascope	Other	Nationwide
17 Dec 2025Device	CLASS II	Cardiosave Hybrid recalled by Datascope	Datascope	Other	Nationwide

All datascope recalls, newest first

134 total

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS III	Battery Charging Station recalled by Datascope	Datascope	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	CS100 IABP recalled by Datascope	Datascope	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	CS300 IABP recalled by Datascope	Datascope	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS III	Cardiosave Hybrid recalled by Datascope	Datascope	Other	Nationwide
24 Dec 2025Device	CLASS III	Cardiosave Rescue recalled by Datascope	Datascope	Other	Nationwide
17 Dec 2025Device	CLASS II	Cardiosave Hybrid recalled by Datascope	Datascope	Other	Nationwide
17 Dec 2025Device	CLASS II	Cardiosave Rescue recalled by Datascope	Datascope	Other	Nationwide
13 Nov 2024Device	CLASS II	MEGA 7.. 40cc Intra-Aortic Balloon with Accessories recalled	Datascope	Packaging Defects	NJ
2 Oct 2024Device	CLASS I	Cardiosave Hybrid Intra-aortic Balloon Pump (iabp) recalled by Datascope	Datascope	Potency & Assay	NJ
2 Oct 2024Device	CLASS I	Cardiosave Rescue Intra-aortic Balloon Pump (iabp) recalled by Datascope	Datascope	Potency & Assay	NJ
2 Oct 2024Device	CLASS I	Cardiosave Rescue Intra-aortic Balloon Pump (iabp) recalled by Datascope	Datascope	Potency & Assay	NJ
2 Oct 2024Device	CLASS I	Cardiosave Hybrid Intra-aortic Balloon Pump (iabp) recalled by Datascope	Datascope	Potency & Assay	NJ
6 Sep 2023Device	CLASS II	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) recalled	Datascope	Device Malfunction	Nationwide
6 Sep 2023Device	CLASS I	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) recalled	Datascope	Device Malfunction	Nationwide
6 Sep 2023Device	CLASS I	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) recalled	Datascope	Device Malfunction	Nationwide
6 Sep 2023Device	CLASS I	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) recalled	Datascope	Temperature Abuse	Nationwide
6 Sep 2023Device	CLASS II	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) recalled	Datascope	Device Malfunction	Nationwide
6 Sep 2023Device	CLASS I	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) recalled	Datascope	Device Malfunction	Nationwide
6 Sep 2023Device	CLASS I	Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) recalled	Datascope	Device Malfunction	Nationwide
6 Sep 2023Device	CLASS I	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) recalled	Datascope	Temperature Abuse	Nationwide
6 Sep 2023Device	CLASS I	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) recalled	Datascope	Device Malfunction	Nationwide
6 Sep 2023Device	CLASS I	Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) recalled	Datascope	Device Malfunction	Nationwide
2 Aug 2023Device	CLASS II	Sensation Plus recalled by Datascope	Datascope	Packaging Defects	Nationwide
2 Aug 2023Device	CLASS II	MEGA. IAB, Intra-Aortic Balloon Catheter and Accessories recalled	Datascope	Packaging Defects	Nationwide
2 Aug 2023Device	CLASS II	Reinforced Introducer Set, Intra-Aortic Balloon Catheter recalled	Datascope	Other	Nationwide
2 Aug 2023Device	CLASS II	MEGA 7..IAB , Intra-Aortic Balloon Catheter and Accessories recalled	Datascope	Packaging Defects	Nationwide
2 Aug 2023Device	CLASS II	Trans-ray IAB, Intra-Aortic Balloon Catheter recalled by Datascope	Datascope	Packaging Defects	Nationwide
2 Aug 2023Device	CLASS II	Sensation Plus recalled by Datascope	Datascope	Packaging Defects	Nationwide
2 Aug 2023Device	CLASS II	Yamato Plus Iab recalled by Datascope	Datascope	Packaging Defects	Nationwide
2 Aug 2023Device	CLASS II	Sensation. IAB, Intra-Aortic Balloon Catheter recalled by Datascope	Datascope	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.