System, balloon, intra-aortic and control

FDA product code DSP · Class 2 · 220 devices · 30,888 reports · 206 deaths reported · 112 devices named in recalls

• Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB 0884-00-0019-12

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I 0884-00-0019-13

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc 0884-00-0019-16

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB 0884-00-0019-17

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT 0684-00-0560-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• CS100 Accessory Kit, Spanish, 220 V 0020-00-0463-05

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA) 0684-00-0561-02

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 7.5Fr. 30cc IAB (with APA) 0684-00-0294-02

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs 0884-00-0019-21

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7 0884-00-0019-22

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 7.5 Fr. 30cc IAB (China) 0684-00-0294-05

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 7.5 Fr. 30cc IAB (China) w/ APA 0684-00-0294-06

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 7.5 Fr. 40cc IAB (China) w/ APA 0684-00-0295-06

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Linear 7.5Fr. 25cc IAB (China) 0684-00-0478-01C

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Linear 7.5Fr. 25cc IAB (with APA) (China) 0684-00-0478-02C

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Linear 7.5Fr. 40cc IAB (with APA) (China) 0684-00-0480-02C

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 7.5Fr. 30cc IAB (W/O Statlock) 0684-00-0294-03

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 7.5Fr. 40cc IAB (W/O Statlock) 0684-00-0295-03

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 8Fr. 50cc IAB (W/O Statlock) 0684-00-0296-03

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Sensation Plus 7.5Fr. 40cc IAB (W/O Statlock) 0684-00-0568-03

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Linear 7.5Fr. 25cc IAB (with APA) US Only 0684-00-0478-02U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 7.5Fr. 30cc IAB with Accessories (APA), US Only 0684-00-0294-02U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Linear 7.5Fr. 25cc IAB (INDIA) 0684-00-0478-07

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Linear 7.5Fr. 25cc IAB (INDIA)(with APA) 0684-00-0478-08

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 8Fr. 50cc IAB (INDIA)(with APA) 0684-00-0498-08

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 7.5 Fr. 30cc IAB W/O Statlock - INDIA 0684-00-0294-07

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 7.5 Fr. 30cc IAB W/O Statlock (APA) - INDIA 0684-00-0294-08

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• MEGA 7.5 Fr. 40cc IAB W/O Statlock (APA) - INDIA 0684-00-0295-08

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Sensation 7Fr 34cc IAB with Accessories (Turkey) 0684-00-0469-09

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Sensation Plus 7.5Fr 40cc IAB with Accessories (Turkey) 0684-00-0568-09

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Linear 7.5Fr 40cc IAB with Accessories (Turkey) 0684-00-0480-09

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Linear 7.5Fr 25cc IAB with Accessories (Turkey) 0684-00-0478-09

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Mega 7.5Fr 30cc IAB with Accessories (Turkey) 0684-00-0294-09

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Mega 7.5Fr 30cc IAB with Accessories (APA) (Turkey) 0684-00-0294-10

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Mega 7.5Fr 40cc IAB with Accessories (Turkey) 0684-00-0295-09

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Mega 7.5Fr 40cc IAB with Accessories (APA) (Turkey) 0684-00-0295-10

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Mega 8Fr 50cc IAB with Accessories (Turkey) 0684-00-0296-09

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Mega 8Fr 50cc IAB with Accessories (APA) (Turkey) 0684-00-0296-10

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• ARROW IPN915320

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 recall0 reports
• ARROW IPN915318

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 recall0 reports
• CS100 Intra-Aortic Balloon Pump, Portuguese, 220V 0998-00-3013-68

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  49 reports
• CS300 Intra-Aortic Balloon Pump, German, 220V 0998-00-3023-61

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 deaths45 reports
• Linear 7.5Fr. 34cc IAB (INDIA) 0684-00-0479-07

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 death44 reports
• ARROW IPN000325

  Teleflex Incorporated · System, balloon, intra-aortic and control
  44 reports
• CS300 Intra-Aortic Balloon Pump, Portuguese, 220V 0998-00-3023-68

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  41 reports
• ARROW IPN915325

  Teleflex Incorporated · System, balloon, intra-aortic and control
  35 reports
• ARROW IPN000255

  Teleflex Incorporated · System, balloon, intra-aortic and control
  32 reports
• ARROW IPN039788

  Teleflex Incorporated · System, balloon, intra-aortic and control
  29 reports
• ARROW IPN039782

  Teleflex Incorporated · System, balloon, intra-aortic and control
  23 reports
• ARROW IPN929208

  Teleflex Incorporated · System, balloon, intra-aortic and control
  23 reports
• Linear 7.5Fr. 34cc IAB with Accessories, US Only 0684-00-0479-01U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 reports
• CS300 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,DOM 0998-UC-3023-53

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 reports
• CS300 Intra-Aortic Balloon Pump - UTS, English, 110V 0998-00-3023-83

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  17 reports
• CS100 Intra-Aortic Balloon Pump, French, 220V 0998-00-3013-64

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  16 reports
• Linear 7.5Fr. 34cc IAB (China) 0684-00-0479-01C

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  16 reports
• ARROW IPN038265

  Teleflex Incorporated · System, balloon, intra-aortic and control
  16 reports
• ARROW IPN039778

  Teleflex Incorporated · System, balloon, intra-aortic and control
  16 reports
• ARROW IPN039783

  Teleflex Incorporated · System, balloon, intra-aortic and control
  16 reports
• CS300 Intra-Aortic Balloon Pump, Refurbished, JAPANESE,NON-UTS,DOM 0998-UC-3023-65

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  15 reports
• ARROW IPN917288

  Teleflex Incorporated · System, balloon, intra-aortic and control
  14 reports
• ARROW IPN000324

  Teleflex Incorporated · System, balloon, intra-aortic and control
  14 reports
• ARROW IPN038077

  Teleflex Incorporated · System, balloon, intra-aortic and control
  13 reports
• CS300 Intra-Aortic Balloon Pump, French, 110V 0998-00-3023-62

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  13 reports
• CS100 Intra-Aortic Balloon Pump, Refurbished, CHINESE,NON-UTS,INTL 0998-UC-3013-45

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  13 reports
• ARROW IPN038075

  Teleflex Incorporated · System, balloon, intra-aortic and control
  12 reports
• CS300 Intra-Aortic Balloon Pump, Spanish, 110V 0998-00-3023-57

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 deaths12 reports
• ARROW IPN039784

  Teleflex Incorporated · System, balloon, intra-aortic and control
  12 reports
• ARROW IPN917286

  Teleflex Incorporated · System, balloon, intra-aortic and control
  12 reports
• ARROW IPN000253

  Teleflex Incorporated · System, balloon, intra-aortic and control
  11 reports
• CS100 Intra-Aortic Balloon Pump, Refurbished, JAPANESE,NON-UTS,DOM 0998-UC-3013-65

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  11 reports
• ARROW IPN038102

  Teleflex Incorporated · System, balloon, intra-aortic and control
  2 deaths10 reports
• ARROW IPN001113

  Teleflex Incorporated · System, balloon, intra-aortic and control
  10 reports
• Linear 7.5Fr. 34cc IAB (with APA) 0684-00-0479-02

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 death9 reports
• CS100 Intra-Aortic Balloon Pump, Refurbished, PORTUGUESE,NON-UTS,DOM 0998-UC-3013-68

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  9 reports
• CS300 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,INT'L 0998-UC-3023-55

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  9 reports
• ARROW IPN915324

  Teleflex Incorporated · System, balloon, intra-aortic and control
  9 reports
• CS300 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,UTS,DOM 0998-UC-3023-83

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  8 reports
• ARROW IPN000329

  Teleflex Incorporated · System, balloon, intra-aortic and control
  8 reports
• ARROW IPN038074

  Teleflex Incorporated · System, balloon, intra-aortic and control
  7 reports
• CS300 Intra-Aortic Balloon Pump, Refurbished, SPANISH,NON-UTS,INT'L 0998-UC-3023-58

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  7 reports
• CS100 Intra-Aortic Balloon Pump, Refurbished, PORTUGUESE,NON-UTS,INTL 0998-UC-3013-69

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  7 reports
• ARROW IPN039787

  Teleflex Incorporated · System, balloon, intra-aortic and control
  7 reports
• ARROW IPN000261

  Teleflex Incorporated · System, balloon, intra-aortic and control
  6 reports
• ARROW IPN039779

  Teleflex Incorporated · System, balloon, intra-aortic and control
  5 reports
• CS100 Intra-Aortic Balloon Pump, German, 220V 0998-00-3013-61

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  4 reports
• ARROW IPN039780

  Teleflex Incorporated · System, balloon, intra-aortic and control
  4 reports
• CS100 UTS Intra-Aortic Balloon Pump SPANISH 110V 0998-00-3013-87

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  3 reports
• CS100 Intra-Aortic Balloon Pump, French, 110V 0998-00-3013-62

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  3 reports
• ARROW IPN039791

  Teleflex Incorporated · System, balloon, intra-aortic and control
  3 reports
• CS100 UTS Intra-Aortic Balloon Pump INTL 220V 0998-00-3013-85

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 reports
• CS100 Intra-Aortic Balloon Pump, Refurbished, GERMAN,NON-UTS,INTL 0998-UC-3013-61

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 reports
• CS100 Intra-Aortic Balloon Pump, Refurbished, ITALIAN,NON-UTS,INTL 0998-UC-3013-67

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 reports
• Linear 7.5Fr. 34cc IAB with Accessories (APA), US Only 0684-00-0479-02U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 reports
• MEGA 7.5Fr. 40cc IAB with Accessories, US Only 0684-00-0295-01U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 reports
• MEGA 7.5Fr. 40cc IAB with Accessories (APA), US Only 0684-00-0295-02U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 reports
• ARROW IPN915328

  Teleflex Incorporated · System, balloon, intra-aortic and control
  2 reports
• ARROW IPN000251

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 report
• CS100 UTS Intra-Aortic Balloon Pump ENG DOMSTC 0998-00-3013-83

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 report
• ASSY,SAFETY DISK,ENGLISH 0997-00-0985-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 report
• CS100 UTS Intra-Aortic Balloon Pump FRENCH 110V 0998-00-3013-92

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 report