Datascope Recalls
134 recalls on record · September 10, 2014 to March 25, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 24, 2019Medical DevicesFDA
Datascope Corp. recalls Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.
Hazard: If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
July 24, 2019Medical DevicesFDA
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
Hazard: Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.
June 20, 2018Medical DevicesFDA
Datascope Corporation recalls Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The
Hazard: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
June 20, 2018Medical DevicesFDA
Datascope Corporation recalls Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: T
Hazard: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
June 20, 2018Medical DevicesFDA
Datascope Corporation recalls Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maq
Hazard: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
June 13, 2018Medical DevicesFDA
Datascope Corporation recalls Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
Hazard: There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
June 13, 2018Medical DevicesFDA
Datascope Corporation recalls Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
Hazard: There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
June 13, 2018Medical DevicesFDA
Datascope Corporation recalls Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
Hazard: There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 22701, Catalog No. 701050790
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
May 16, 2018Medical DevicesFDA
Datascope Corporation recalls BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
Hazard: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.