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

• CARDIOSAVE HYBRID, TYPE B PLUG 0998-00-0800-53

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls39 deaths10,316 reports
• CS300 Intra-Aortic Balloon Pump, English, 110V 0998-00-3023-53

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  12 deaths3,164 reports
• CARDIOSAVE HYBRID W/ E/F PLUG 0998-00-0800-55

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls8 deaths1,686 reports
• CARDIOSAVE HYBRID, TYPE I PLUG 0998-00-0800-45

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls5 deaths1,181 reports
• CARDIOSAVE HYBRID, TYPE G PLUG 0998-00-0800-52

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls2 deaths1,157 reports
• SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) 0684-00-0576-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 recalls33 deaths1,541 reports
• CARDIOSAVE RESCUE 0998-00-0800-83

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  26 recalls167 reports
• CARDIOSAVE HYBRID, 3.1 EDITION 0998-00-0800-65

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls3 deaths456 reports
• CARDIOSAVE HYBRID TYPE I (AU) 0998-00-0800-31

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls232 reports
• CARDIOSAVE HYBRID TYPE D PLUG 0998-00-0800-33

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls2 deaths230 reports
• CARDIOSAVE HYBRID TYPE J PLUG 0998-00-0800-32

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls2 deaths48 reports
• CARDIOSAVE RESCUE, CHINESE 0998-00-0800-75

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls12 reports
• CS300 Intra-Aortic Balloon Pump, English, 220V 0998-00-3023-55

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 deaths1,062 reports
• CARDIOSAVE RESCUE, 3.1 EDITION 0998-00-0800-85

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls1 report
• CARDIOSAVE HYBRID TYPE M PLUG 0998-00-0800-35

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls13 reports
• CS100 Intra-Aortic Balloon Pump, English, 220V 0998-00-3013-55

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  4 deaths933 reports
• CARDIOSAVE HYBRID TYPE K PLUG 0998-00-0800-34

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  15 recalls0 reports
• ARROW IPN000260

  Teleflex Incorporated · System, balloon, intra-aortic and control
  4 deaths698 reports
• CS100 Intra-Aortic Balloon Pump, Chinese, 220V 0998-00-3013-45

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 deaths684 reports
• SENSATION PLUS 7.5Fr. 40cc IAB & Accessories 0684-00-0568-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 recalls10 deaths407 reports
• CARDIOSAVE HYBRID - TYPE "N" PLUG 0998-00-0800-36

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  9 recalls1 death16 reports
• ARROW IPN000254

  Teleflex Incorporated · System, balloon, intra-aortic and control
  5 deaths441 reports
• ARROW IPN001112

  Teleflex Incorporated · System, balloon, intra-aortic and control
  394 reports
• ARROW IPN000320

  Teleflex Incorporated · System, balloon, intra-aortic and control
  2 deaths383 reports
• CS100 Intra-Aortic Balloon Pump, English, 110V 0998-00-3013-53

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 death379 reports
• ARROW IPN000263

  Teleflex Incorporated · System, balloon, intra-aortic and control
  3 deaths347 reports
• CS300 Intra-Aortic Balloon Pump, Japanese, 110V 0998-00-3023-65

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  3 deaths326 reports
• Sensation 7Fr. 40cc IAB 0684-00-0470-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall14 deaths247 reports
• CS300 Intra-Aortic Balloon Pump, Chinese, 220V 0998-00-3023-45

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 death235 reports
• ARROW IPN000257

  Teleflex Incorporated · System, balloon, intra-aortic and control
  3 deaths233 reports
• Linear 7.5Fr. 40cc IAB 0684-00-0480-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall4 deaths168 reports
• MEGA 8Fr. 50cc IAB 0684-00-0498-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 recalls113 reports
• TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES 0684-00-0607

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 death157 reports
• TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES 0684-00-0608

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall2 deaths152 reports
• CS300 Intra-Aortic Balloon Pump, Italian, 220V 0998-00-3023-67

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  201 reports
• MEGA 8Fr. 50cc IAB (with Statlock) 0684-00-0296-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall5 deaths141 reports
• ARROW IPN000262

  Teleflex Incorporated · System, balloon, intra-aortic and control
  3 deaths170 reports
• Sensation 7Fr. 34cc IAB 0684-00-0469-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall3 deaths116 reports
• CS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,DOM 0998-UC-3013-53

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  160 reports
• ARROW IPN038264

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 recall108 reports
• Sensation Plus 8Fr. 50cc IAB with Accessories, US Only 0684-00-0576-01U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 recalls56 reports
• ARROW IPN917285

  Teleflex Incorporated · System, balloon, intra-aortic and control
  148 reports
• MEGA 7.5Fr. 40cc IAB 0684-00-0295-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 recalls4 deaths38 reports
• CS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,INTL 0998-UC-3013-55

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 death129 reports
• MEGA 7.5 Fr. 40cc IAB (China) 0684-00-0295-05

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall2 deaths79 reports
• Linear 7.5Fr. 40cc IAB (with APA) 0684-00-0480-02

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 recalls1 death26 reports
• ARROW IPN929209

  Teleflex Incorporated · System, balloon, intra-aortic and control
  121 reports
• Linear 7.5Fr. 40cc IAB (INDIA) 0684-00-0480-07

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall2 deaths63 reports
• CS100 Intra-Aortic Balloon Pump, Japanese, 110V 0998-00-3013-65

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 death60 reports
• MEGA 8Fr. 50cc IAB with Accessories, US Only 0684-00-0296-01U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 recalls9 reports
• Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr 0884-00-0019-23

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 recalls2 reports
• CS100 Intra-Aortic Balloon Pump, Spanish, 220V 0998-00-3013-58

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall32 reports
• CS300 Intra-Aortic Balloon Pump, French, 220V 0998-00-3023-64

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  82 reports
• Linear 7.5Fr. 40cc IAB (China) 0684-00-0480-01C

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 death32 reports
• ARROW IPN915322

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 recall29 reports
• Sensation Plus 7.5Fr. 40cc IAB with Accessories, US Only 0684-00-0568-01U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall24 reports
• YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT 0684-00-0559-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall19 reports
• MEGA 7.5Fr. 40cc IAB (with APA) 0684-00-0295-02

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall2 deaths19 reports
• ARROW IPN915319

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 recall17 reports
• CS100 Intra-Aortic Balloon Pump, Portuguese, 110V 0998-00-3013-69

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  66 reports
• CS300 Intra-Aortic Balloon Pump, Spanish, 220V 0998-00-3023-58

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  66 reports
• CS100 Intra-Aortic Balloon Pump, Italian, 220V 0998-00-3013-67

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  65 reports
• MEGA 8Fr. 50cc IAB (with Statlock & APA) 0684-00-0296-02

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall14 reports
• ARROW IPN039793

  Teleflex Incorporated · System, balloon, intra-aortic and control
  62 reports
• ARROW IPN000252

  Teleflex Incorporated · System, balloon, intra-aortic and control
  61 reports
• MEGA 7.5Fr. 30cc IAB 0684-00-0294-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall2 deaths11 reports
• Linear 7.5Fr. 25cc IAB 0684-00-0478-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall8 reports
• Linear 7.5Fr. 34cc IAB 0684-00-0479-01

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 deaths58 reports
• Sensation 7Fr. 40cc IAB (China) 0684-00-0470-01C

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall8 reports
• ARROW IPN916138

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 recall8 reports
• ARROW IPN915321

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 recall7 reports
• ARROW IPN929210

  Teleflex Incorporated · System, balloon, intra-aortic and control
  57 reports
• Linear 7.5Fr. 40cc IAB with Accessories, US Only 0684-00-0480-01U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 death6 reports
• Sensation 7Fr. 34cc IAB (China) 0684-00-0469-01C

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall5 reports
• Sensation 7Fr. 40cc IAB (INDIA) 0684-00-0470-07

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall5 reports
• MEGA 7.5 Fr. 40cc IAB W/O Statlock - INDIA 0684-00-0295-07

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall5 reports
• Sensation Plus 8Fr 50cc IAB With Accessories (w/Pressure Tubes, No Stylet, w/o S 0684-00-0576-05

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall4 reports
• Linear 7.5Fr. 25cc IAB with Accessories, US Only 0684-00-0478-01U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall4 reports
• ARROW IPN915317

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 recall4 reports
• ARROW IPN000302

  Teleflex Incorporated · System, balloon, intra-aortic and control
  54 reports
• Sensation Plus 7.5Fr. 40cc IAB W/ Accessories (W/O Statlock)(China) 0684-00-0568-05

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall3 reports
• Sensation 7Fr. 40cc IAB with Accessories, US Only 0684-00-0470-01U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall3 reports
• MEGA 8Fr. 50cc IAB (INDIA) 0684-00-0498-07

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall3 reports
• CARDIOSAVE BATTERY CHARGING STATION 0998-00-0802

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall3 reports
• YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA) 0684-00-0559-02

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall2 reports
• Linear 7.5Fr. 40cc IAB (INDIA) (with APA) 0684-00-0480-08

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall2 reports
• Sensation 7Fr 40cc IAB with Accessories (Turkey) 0684-00-0470-09

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall2 reports
• Linear 7.5Fr 40cc IAB with Accessories (APA) (Turkey) 0684-00-0480-10

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall2 reports
• Linear 7.5Fr. 25cc IAB (with APA) 0684-00-0478-02

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 report
• Sensation Plus 8Fr. 50cc IAB (W/O Statlock) 0684-00-0576-03

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 report
• Linear 7.5Fr. 40cc IAB with Accessories (APA), US Only 0684-00-0480-02U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 report
• Sensation 7FR. 34cc IAB with Accessories, US Only 0684-00-0469-01U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 report
• MEGA 7.5Fr. 30cc IAB with Accessories, US Only 0684-00-0294-01U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 report
• MEGA 8Fr. 50cc IAB with Accessories (APA), US Only 0684-00-0296-02U

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 report
• Sensation 7Fr. 34cc IAB (INDIA) 0684-00-0469-07

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 report
• Sensation Plus 8Fr 50cc IAB with Accessories (Turkey) 0684-00-0576-09

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 report
• Linear 7.5Fr 25cc IAB with Accessories (APA) (Turkey) 0684-00-0478-10

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 report
• Ultra IABP Catheter Kit IMU7F-30

  Insightra Medical, Inc. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Ultra IABP Catheter Kit IMU7F-35

  Insightra Medical, Inc. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• Ultra IABP Catheter Kit IMU7F-40

  Insightra Medical, Inc. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports