Every recall we track for Datascope Corp. — 67 in all — plus the complaints and injury reports the public filed about them.
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.
Datascope recalls CS100 IABP devices with software version Q.01 due to outdated battery specifications in instructions. Owners should check their device details and contact Datascope for updates.
Datascope recalls CS300 IABP devices with software version C.01 due to outdated battery specifications in instructions.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.
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pump systems with specific model numbers due to updated preventative maintenance requirements from June 2023.
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pump systems with updated preventative maintenance schedule to align with June 2:2023 service manual changes.
Datascope recalls Cardiosave Hybrid models with specific serial numbers due to outdated vibration and shock table standards in the user manual. Affected units require IFU addendum for correct standards.
Datascope recalls Cardiosave Rescue devices with model 0998-00-080: IFU addendum updates vibration/shock table standards. All units affected.
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.
Datascope recalls Cardiosave Hybrid IABP devices due to potential hemodynamic instability and clinical data transmission failure. Affected units have specific product numbers and UDI codes.
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.
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) due to risk of hemodynamic instability and clinical data transmission failure. Affected units have specific product numbers and UDI codes.
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.
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific part numbers due to potential failure in the IAB Fiber Optic Sensor input during connector insertion.
Datascope recalls specific Cardiosave Hybrid Intra-Aortic Balloon Pumps due to potential autofill failure causing pump stops. Affected units have listed part numbers and UDI codes.
Datascope recalls specific Cardiosave Rescue Intra-Aortic Balloon Pumps due to gas circuit alarms triggered by patient movement, coughing, or swallowing. Affected units have unique part numbers and lot numbers.
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific part numbers due to reported overheating causing system shutdowns. Affected units may lose pumping function and enter standby mode.
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.
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.
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific part numbers due to improper console insertion preventing battery charging. Affected units may not charge if the console isn't fully inserted into the hospital cart.
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.
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.
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.
Datascope recalls SENSATION PLUS 8Fr IAB catheters due to risk of introducer dilator fracturing during insertion, potentially causing artery damage or embolization. 10 complaints include 3 serious events and 1 death.
Datascope recalls MEGA 8Fr IAB catheters due to potential introducer dilator fracture during insertion, risking artery damage or embolization. 10 complaints include 3 serious events and 1 death.
Datascope recalls reinforced introducer sets for IAB catheter use due to fracture risk during insertion, potentially causing arterial damage or embolization. 10 complaints including 3 serious events and 1 death reported.
Datascope recalls MEGA 7.5Fr IAB catheters due to risk of introducer dilator fracture during insertion, potentially causing arterial damage or embolization. 10 complaints including 3 serious events and 1 death reported.
Datascope recalls TRANS-RAY IAB catheters due to risk of introducer dilator fracture during insertion, potentially causing arterial damage or embolization. 10 complaints including 3 serious events and 1 death reported.
Datascope recalls SENSATION PLUS 7.5Fr IAB catheters due to risk of introducer dilator fracturing during insertion, potentially causing arterial damage or embolization. 10 complaints include 3 serious events and 1 death.
Datascope recalls YAMATO PLUS IAB catheters due to potential introducer dilator fracture during insertion, risking artery damage or embolization. 10 complaints include 3 serious events and 1 death.
Datascope recalls SENSATION 7 Fr. IAB catheters due to potential introducer dilator fracture during insertion, risking artery damage or embolization. 10 complaints including 3 serious events and 1 death reported.
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.
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific model numbers due to potential unexpected shutdowns from capacitor failures, which may interrupt therapy.
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.
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific model numbers due to potential battery charging issues that could interrupt therapy.
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.
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.
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.
Datascope recalls Cardiosave IABP Pneumatic Interface Module Model 0997-00-1178 due to potential safety disk failure causing reduced inflation during therapy. Affected units have specific serial numbers listed.
Datascope recalls Cardiosave Intra-Aortic Balloon Pump Safety Disk Model 0202-00-0140 with serial numbers listed. The Safety Disk may cause slightly reduced inflation during therapy, potentially affecting patient augmentation.
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to a Safety Disk that may not meet performance requirements, potentially reducing IAB inflation during therapy. Affected units include model numbers 0998-00-0800-31 through 0998-00-0800-65 and associated serial numbers.
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.
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with faulty Coiled Cord cable that may cause unexpected shutdowns. Affected models include specific serial numbers and UDI-DI codes.
Datascope recalls Cardiosave Rescue models 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85 due to potential unexpected shutdowns that could interrupt therapy and threaten patient hemodynamic stability.
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.
Datascope recalls specific Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may cause insufficient helium in the pump reservoir during use.
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.
Datascope recalls Cardiosave Rescue Model 0998-00-0800-83 due to helium leaks from damaged O-rings causing therapy interruptions. Affected units may need repair or replacement.
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.
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.
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific model numbers due to risk of unexpected shutdown from blood entering the device during therapy with a compromised catheter.
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.
Datascope recalls Cardiosave Hybrid IntraAortic Balloon Pumps with specific model numbers due to risk of fluid ingress causing system shutdown and unsafe hemodynamic instability.
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.
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.
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pump models 0998-00-0800-75, 83, 85 due to helium indicator potentially overestimating helium levels in electromagnetic interference.
Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pump models 0998-00-0800-75, 83, 85 due to risk of unexpected shutdown when running on AC power with one battery installed and being charged.
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential helium indicator inaccuracies in electromagnetic interference.
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.
Datascope recalls Cardiosave Hybrid IABP devices due to cybersecurity vulnerabilities that could disconnect hospital information systems. Affected models include specific serial numbers and system versions. No remedy is listed in the official recall notice.
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.
