PlainRecalls

Datascope Corp.

48 recalls on record · Latest: Mar 11, 2026

Datascope Corp. Recall Insight

Datascope Corp. appears on 48 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.057% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 11, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 48 entries, severity tagging shows 22 critical, 22 moderate, and 4 lower-severity recalls. Affected-unit counts are disclosed on 48 of 48 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (48). The date window on this page runs from Jul 24, 2019 to Mar 11, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Mar 11, 2026

CS300 IABP. Software Version CS300 IABP C.01.

FDA Devices Moderate Mar 11, 2026

CS100 IABP. Software Version CS100 IABP Q.01.

FDA Devices Low Dec 24, 2025

Cardiosave Rescue

FDA Devices Low Dec 24, 2025

Cardiosave Hybrid

FDA Devices Moderate Dec 17, 2025

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

FDA Devices Moderate Dec 17, 2025

Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

FDA Devices Moderate Nov 13, 2024

MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

FDA Devices Critical Oct 2, 2024

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

FDA Devices Critical Oct 2, 2024

CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

FDA Devices Critical Oct 2, 2024

CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

FDA Devices Critical Sep 6, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33…

FDA Devices Critical Sep 6, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33…

FDA Devices Critical Sep 6, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33…

FDA Devices Critical Sep 6, 2023

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

FDA Devices Critical Sep 6, 2023

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

FDA Devices Moderate Sep 6, 2023

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

FDA Devices Moderate Aug 2, 2023

LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …

FDA Devices Moderate Aug 2, 2023

SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …

FDA Devices Moderate Aug 2, 2023

YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description …

FDA Devices Moderate Aug 2, 2023

SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descriptio…

FDA Devices Moderate Aug 2, 2023

TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …

FDA Devices Moderate Aug 2, 2023

MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …

FDA Devices Critical Jul 26, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-…

FDA Devices Critical Jul 26, 2023

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

FDA Devices Critical Jul 26, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-…

FDA Devices Critical Jul 26, 2023

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

FDA Devices Low Jun 21, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

FDA Devices Moderate May 3, 2023

MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32

FDA Devices Moderate Mar 29, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

FDA Devices Moderate Mar 29, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45…

FDA Devices Moderate Mar 15, 2023

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85

FDA Devices Moderate Mar 15, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998…

FDA Devices Moderate Mar 15, 2023

Cardiosave Rescue. Model Number: 0998-00-0800-83.

FDA Devices Critical Mar 15, 2023

Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52…

FDA Devices Moderate Mar 15, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35…

FDA Devices Critical Jan 25, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35…

FDA Devices Critical Dec 22, 2021

Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-…

FDA Devices Critical Oct 27, 2021

Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numb…

FDA Devices Moderate Oct 13, 2021

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0…

FDA Devices Moderate Oct 6, 2021

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0…

FDA Devices Low May 5, 2021

Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via th…

FDA Devices Moderate Nov 13, 2019

Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589…

FDA Devices Critical Jul 24, 2019

CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.

FDA Devices Critical Jul 24, 2019

CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.

FDA Devices Critical Jul 24, 2019

CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.

FDA Devices Critical Jul 24, 2019

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.

FDA Devices Critical Jul 24, 2019

CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.

FDA Devices Critical Jul 24, 2019

Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Datascope Corp. with FORD →

Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds