Datascope recalls

Datascope appears in 134 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-…
  FDA Device · Class I · 2023-01-25 · Datascope
• LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter
  FDA Device · Class II · 2022-11-02 · Datascope
• Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
  FDA Device · Class II · 2022-09-14 · Datascope
• MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
  FDA Device · Class II · 2022-09-14 · Datascope
• Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
  FDA Device · Class II · 2022-09-14 · Datascope
• Cardiosave Rescue IntraAortic Balloon Pump
  FDA Device · Class I · 2021-12-22 · Datascope
• Cardiosave Hybrid IntraAortic Balloon Pump
  FDA Device · Class I · 2021-12-22 · Datascope
• Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097
  FDA Device · Class I · 2021-10-27 · Datascope
• Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
  FDA Device · Class II · 2021-10-13 · Datascope
• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-…
  FDA Device · Class II · 2021-10-13 · Datascope
• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-…
  FDA Device · Class II · 2021-10-06 · Datascope
• Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
  FDA Device · Class II · 2021-10-06 · Datascope
• Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons
  FDA Device · Class III · 2021-05-05 · Datascope
• Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons
  FDA Device · Class III · 2021-05-05 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-0…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05,…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-02…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications F…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications F…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use:…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications F…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-0…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 068…
  FDA Device · Class II · 2020-09-02 · Datascope
• Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-…
  FDA Device · Class II · 2020-09-02 · Datascope
• Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310
  FDA Device · Class II · 2020-02-12 · Datascope
• Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06
  FDA Device · Class II · 2020-02-12 · Datascope
• Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305
  FDA Device · Class II · 2020-02-12 · Datascope
• Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-…
  FDA Device · Class II · 2019-11-13 · Datascope
• CS100 Intra-Aortic Balloon Pump, English, 220V
  FDA Device · Class I · 2019-07-24 · Datascope
• Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.…
  FDA Device · Class II · 2019-07-24 · Datascope
• Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use
  FDA Device · Class I · 2019-07-24 · Datascope
• CS300 Intra-Aortic Balloon Pump, English, 220V
  FDA Device · Class I · 2019-07-24 · Datascope
• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use
  FDA Device · Class I · 2019-07-24 · Datascope
• CS300 Intra-Aortic Balloon Pump, English, 110V
  FDA Device · Class I · 2019-07-24 · Datascope
• CS100 Intra-Aortic Balloon Pump, English, 110V
  FDA Device · Class I · 2019-07-24 · Datascope
• Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary…
  FDA Device · Class II · 2018-06-20 · Datascope
• Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmona…
  FDA Device · Class II · 2018-06-20 · Datascope
• Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Byp…
  FDA Device · Class II · 2018-06-20 · Datascope
• Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
  FDA Device · Class III · 2018-06-13 · Datascope
• Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
  FDA Device · Class III · 2018-06-13 · Datascope
• Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
  FDA Device · Class III · 2018-06-13 · Datascope
• BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
  FDA Device · Class II · 2018-05-16 · Datascope
• BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
  FDA Device · Class II · 2018-05-16 · Datascope