Datascope Recalls
131 recalls on record in the United States
Datascope Corporation recalls SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with
Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified.
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Datascope Corporation recalls Custom Tubing Pack with Bioline Coating UDI code: 006075672
A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.
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Datascope Corp. recalls CS300 IABP. Software Version CS300 IABP C.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
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Datascope Corp. recalls CS100 IABP. Software Version CS100 IABP Q.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
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Datascope Corp. recalls Cardiosave Rescue
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
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Datascope Corp. recalls Cardiosave Hybrid
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
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Datascope Corp. recalls Cardiosave Rescue. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
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Datascope Corp. recalls Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
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Datascope Corp. recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Mode
There is discrepant labeling on the inner and outer packaging of the device.
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Datascope Corp. recalls CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electrom
Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
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Datascope Corp. recalls CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electrom
Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
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Datascope Corp. recalls CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electrom
Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
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Datascope Corp. recalls CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electrom
Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
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Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Nu
Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
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Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Nu
Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kins and abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The HHE also identified hardware issues related to these alarms.
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Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Nu
Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
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Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Nu
Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
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Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Nu
Users were identifying autofill failure conditions on the devices causing pump stops.
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Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Nu
Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
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Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Nu
Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
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Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Nu
Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kinks/abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The firm's HHE also identified hardware issues related to these alarms.
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Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Nu
Users were identifying autofill failure conditions on the devices causing pump stops.
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Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Nu
Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
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Datascope Corp. recalls LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessor
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
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Datascope Corp. recalls SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Acces
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
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Datascope Corp. recalls YAMATO PLUS IAB; intra-aortic balloon catheter and accessori
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
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Datascope Corp. recalls SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
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Datascope Corp. recalls TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
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Datascope Corp. recalls MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessori
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
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Datascope Corp. recalls REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
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Showing 30 of 131 recalls. See all →