Datascope Corp.
Complete recall history across all FDA and CPSC categories — 67 total recalls
Datascope Corp. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (67)
FDA medical device enforcement actions by Datascope Corp.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 6, 2026 | Battery Charging Station; Model: 0998-00-0802; | The Battery Charging Station is an optional dual-bay charger used to charge ... | Class III |
| Jan 23, 2026 | CS100 IABP. Software Version CS100 IABP Q.01. | The firm has identified that the battery runtime and cycle specifications con... | Class II |
| Jan 23, 2026 | CS300 IABP. Software Version CS300 IABP C.01. | The firm has identified that the battery runtime and cycle specifications con... | Class II |
| Nov 4, 2025 | Cardiosave Hybrid. Intra-Aortic Balloon Pump system. | The IFU addendum revises the Preventative Maintenance schedule to align with ... | Class II |
| Nov 4, 2025 | Cardiosave Rescue. Intra-Aortic Balloon Pump system. | The IFU addendum revises the Preventative Maintenance schedule to align with ... | Class II |
| Oct 23, 2025 | Cardiosave Hybrid | The IFU addendum updates the Vibration and Shock Table to reference the corre... | Class III |
| Oct 23, 2025 | Cardiosave Rescue | The IFU addendum updates the Vibration and Shock Table to reference the corre... | Class III |
| Sep 17, 2024 | MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-... | There is discrepant labeling on the inner and outer packaging of the device. | Class II |
| Aug 8, 2024 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.01) for outside the US t... | Class I |
| Aug 8, 2024 | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.01) for outside the US t... | Class I |
| Aug 8, 2024 | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.00) outside the US to mi... | Class I |
| Aug 8, 2024 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.00) outside the US to mi... | Class I |
| Jul 31, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were experiencing a failure in the IAB Fiber Optic Sensor input on the ... | Class II |
| Jul 31, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were identifying autofill failure conditions on the devices causing pum... | Class I |
| Jul 31, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in ... | Class I |
| Jul 31, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users reported "System Over Temperature" alarms associated with a loss of pum... | Class I |
| Jul 31, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were experiencing a failure in the IAB Fiber Optic Sensor input on the ... | Class II |
| Jul 31, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were identifying autofill failure conditions on the devices causing pu... | Class I |
| Jul 31, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were reporting that the device was not charging as expected. It was dis... | Class I |
| Jul 31, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users reported "System Over Temperature" alarms associated with a loss of pum... | Class I |
| Jul 31, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in ... | Class I |
| Jul 31, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were reporting that the device was not charging as expected. It was dis... | Class I |
| Jun 23, 2023 | SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used ... | During IAB catheter insertion, the introducer dilator may fracture at the hub... | Class II |
| Jun 23, 2023 | MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide... | During IAB catheter insertion, the introducer dilator may fracture at the hub... | Class II |
| Jun 23, 2023 | REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, use... | During IAB catheter insertion, the introducer dilator may fracture at the hub... | Class II |
| Jun 23, 2023 | MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provi... | During IAB catheter insertion, the introducer dilator may fracture at the hub... | Class II |
| Jun 23, 2023 | TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide... | During IAB catheter insertion, the introducer dilator may fracture at the hub... | Class II |
| Jun 23, 2023 | SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used... | During IAB catheter insertion, the introducer dilator may fracture at the hub... | Class II |
| Jun 23, 2023 | YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provid... | During IAB catheter insertion, the introducer dilator may fracture at the hub... | Class II |
| Jun 23, 2023 | SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to p... | During IAB catheter insertion, the introducer dilator may fracture at the hub... | Class II |
| Jun 23, 2023 | LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to prov... | During IAB catheter insertion, the introducer dilator may fracture at the hub... | Class II |
| Jun 5, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... | An unexpected shutdown of the IABP may occur due to failures of tantalum capa... | Class I |
| Jun 5, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... | An unexpected shutdown of the IABP may occur due to failures of tantalum capa... | Class I |
| Jun 5, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... | IABP may lose the ability to charge batteries in one or both bay slots. Th... | Class I |
| Jun 5, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... | IABP may lose the ability to charge batteries in one or both bay slots. Th... | Class I |
| May 4, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-080... | The digital IFUs provided with the Cardiosave IABP during the software update... | Class III |
| Apr 4, 2023 | MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 | The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to... | Class II |
| Feb 28, 2023 | Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) ... | There is an issue related to the Safety Disk not meeting a performance requir... | Class II |
| Feb 28, 2023 | Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00... | There is an issue related to the Safety Disk not meeting a performance requir... | Class II |
| Feb 28, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | There is an issue related to the Safety Disk not meeting a performance requir... | Class II |
| Feb 28, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbe... | There is an issue related to the Safety Disk not meeting a performance requir... | Class II |
| Feb 7, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord c... | An unexpected shutdown of the IABP may occur due to a failure of the connecti... | Class I |
| Feb 7, 2023 | Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-08... | An unexpected shutdown of the IABP may occur due to loss of communication bet... | Class I |
| Feb 7, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord c... | An unexpected shutdown of the IABP may occur due to a failure of the connecti... | Class I |
| Feb 7, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | There have been reported failures of the high pressure helium regulator, whic... | Class II |
| Feb 7, 2023 | Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-080... | An unexpected shutdown of the IABP may occur due to loss of communication bet... | Class I |
| Feb 7, 2023 | Cardiosave Rescue. Model Number: 0998-00-0800-83. | Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave... | Class II |
| Feb 7, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, ... | Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave... | Class II |
| Feb 7, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | There have been reported failures of the high pressure helium regulator, whic... | Class II |
| Dec 19, 2022 | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | The Cardiosave IABP may shut down unexpectedly due to blood entering in the C... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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