Datascope Corp. recalls
Every recall we track for Datascope Corp. — 67 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them. 9 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Datascope Corp. peaked in 2023 (37); 67 since 2017. 13% rated “stop using now”.
All FDA recall records for Datascope Corp. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 3 | 4 | 0 | 7 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 4 | 3 | 2 | 9 |
| 2022 | 0 | 2 | 0 | 0 | 2 |
| 2023 | 9 | 22 | 5 | 1 | 37 |
| 2024 | 0 | 4 | 1 | 0 | 5 |
| 2025 | 0 | 0 | 4 | 0 | 4 |
| 2026 (to date) | 0 | 0 | 3 | 0 | 3 |
What to do if you have a recalled Datascope Corp. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Datascope Corp. recalls
30 shown- Lower riskMedical device
Datascope Corp. recalls Battery Charging Station; Model: 0998-00-0802;
Datascope recalls Battery Charging Station model 0998-00-0802 due to a protruding screw that limits battery insertion and prevents proper charging. Affected units have specific serial numbers and were sold with Cardiosave IABP Lithium-Ion batteries.
DatascopeFeb 6, 2026 - Lower riskMedical device
Datascope Corp. recalls CS300 IABP. Software Version CS300 IABP C.01.
Datascope recalls CS300 IABP devices with software version C.01 due to outdated battery specifications in instructions. Affected units may have safety risks requiring software update.
DatascopeJan 23, 2026 - Lower riskMedical device
Datascope Corp. recalls Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pump systems with updated preventative maintenance schedule to align with June 2:2023 service manual changes.
DatascopeNov 4, 2025 - Lower riskMedical device
Datascope Corp. recalls Cardiosave Rescue
Datascope recalls Cardiosave Rescue devices with model 0998-00-080: IFU addendum updates vibration/shock table standards. All units affected.
DatascopeOct 23, 2025 - Lower riskMedical device
Datascope Corp. recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Datascope recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories (Model 0684-00-0295-01) due to discrepant labeling on inner and outer packaging. Affected units may have safety risks.
DatascopeSep 17, 2024 - Use cautionMedical device
Datascope Corp. recalls CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) due to software issues that may cause hemodynamic instability and clinical data transmission failure. Affected units have specific product numbers and UDI codes.
DatascopeAug 8, 2024 - Use cautionMedical device
Datascope Corp. recalls CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic
Datascope recalls Cardiosave Hybrid IABP devices due to potential hemodynamic instability and clinical data transmission failure. Affected units include specific product numbers and UDI codes.
DatascopeAug 8, 2024 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope recalls Cardiosave IABP pumps with specific part numbers due to potential fiber optic sensor failure during use. Affected units may have safety risks during medical procedures.
DatascopeJul 31, 2023 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific part numbers due to risk of unexpected pump stops during use. Affected units may require replacement.
DatascopeJul 31, 2023 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32,
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific part numbers due to overheating alarms causing system shutdowns. Affected units may lose pumping function and enter standby mode.
DatascopeJul 31, 2023 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32,
Datascope recalls specific Cardiosave Hybrid Intra-Aortic Balloon Pumps due to gas circuit alarms triggered by patient movement like coughing or swallowing, which could cause incorrect therapy alerts.
DatascopeJul 31, 2023 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32,
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific part numbers due to battery charging issues when the console isn't fully inserted into the hospital cart.
DatascopeJul 31, 2023 - Stop using nowMedical device
Datascope Corp. recalls LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta
Datascope recalls LINEAR 7.5Fr IAB catheters due to potential introducer dilator fracture during insertion, risking artery damage or embolization. 10 complaints include 3 serious events and 1 death.
DatascopeJun 23, 2023 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential unexpected shutdowns from capacitor failures, which could interrupt life-saving therapy.
DatascopeJun 5, 2023 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential battery charging failures that could interrupt therapy. Affected units may require replacement to prevent therapy interruptions.
DatascopeJun 5, 2023 - Lower riskMedical device
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential non-compliance with safety standard 60601-1-12:2014 after a software update.
DatascopeMay 4, 2023 - UnratedMedical device
Datascope Corp. recalls MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Datascope Corp. recalls Cardiosave Hybrid IABP pumps with specific model numbers due to incompatible Brazilian power cord. Affected units may not operate safely in Brazil.
MAQUETApr 4, 2023 - Lower riskMedical device
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83,
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential safety disk issues that could reduce inflation during therapy. Affected units include model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85.
DatascopeFeb 28, 2023 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with faulty Coiled Cord cable that may cause unexpected shutdowns. Affected models include 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. Contact for remedy.
DatascopeFeb 7, 2023 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35
Datascope recalls Cardiosave Hybrid models 0998-00-0800-31 to 0998-00-0800-65 due to potential IABP shutdown causing therapy interruption and hemodynamic instability.
DatascopeFeb 7, 2023 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33,
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to damaged O-rings causing helium leaks that may interrupt therapy. Affected units include D998-00-0800-31 to D998-UC-0800-55.
DatascopeFeb 7, 2023 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific model numbers due to potential helium regulator failure causing leaks and insufficient helium in the pump reservoir.
DatascopeFeb 7, 2023 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33,
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential unexpected shutdown from blood entering the device during therapy with a compromised catheter.
DatascopeDec 19, 2022 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83,
Datascope recalls Cardiosave Rescue IntraAortic Balloon Pumps with specific model numbers due to risk of fluid entering the device, potentially causing system shutdown and unsafe hemodynamic instability.
DatascopeNov 15, 2021 - Lower riskMedical device
Datascope Corp. recalls Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump
Datascope recalls Cardiosave Li-Ion Battery Packs (Part No. 0146-00-0097) used in Cardiosave Hybrid and Rescue IABP models due to failing runtime tests. Affected units have specific model and serial numbers.
DatascopeSep 21, 2021 - Lower riskMedical device
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33,
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential helium indicator inaccuracies in electromagnetic interference.
DatascopeSep 8, 2021 - Use cautionMedical device
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33,
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to risk of unexpected shutdown when running on AC power, potentially causing harm during critical medical use.
DatascopeSep 8, 2021 - UnratedMedical device
Datascope Corp. recalls Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary
Datascope recalls Cardiosave Rescue IABP devices due to cybersecurity vulnerabilities that could disrupt hospital information systems. Affected models include 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. No remedy is specified in the recall notice.
DatascopeMar 22, 2021 - Lower riskMedical device
Datascope Corp. recalls Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps
Datascope recalls a specific low level output cable for cardiac pumps due to incorrect cable in packaging. Affected units may have safety risks.
DatascopeOct 3, 2019 - Lower riskMedical device
Datascope Corp. recalls CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
Datascope recalls CS100 Intra-Aortic Balloon Pumps with serial numbers 0998-00-3013-55 due to potential battery run time issues. Revised labeling and training are provided to address the risk.
DatascopeJun 17, 2019
Datascope Corp. recall questions
How many recalls has Datascope Corp. had?
67 recalls from Datascope Corp. are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Datascope Corp. recall?
Datascope Corp. recalls Battery Charging Station; Model: 0998-00-0802;, dated Feb 6, 2026. Every Datascope Corp. recall is listed on this page, newest first.
What should I do if I have a recalled Datascope Corp. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Datascope Corp. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.