Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part… recallZ-2435-2023 · Datascope Corp. · initiated Jul 31, 2023

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. Gas Loss & Gas Gain Alarms User Actions to be taken now: Our records indicate that you may have a Cardiosave Hybrid and/or Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) affected by this correction in your facility. Please examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. The following actions should be taken should you experience an alarm for Gas Loss in IAB & Gas Gain in IAB : Gas Gain in IAB Circuit " Verify all of the tubing connections are leak free. " Press the START key to initiate an Autofill and resume pumping. Gas Loss in IAB Circuit " Inspect the tubing from the patient through to the connection of the helium extender tubing to the female luer port of the Cardiosave IABP. " If any blood is noted or perforation is suspected, the following procedure must be performed immediately: 1. Disconnect the catheter extender tubing from the IABP console to allow the balloon to deflate. 2. Clamp extracorporeal tubing between white y-fitting and male connector. 3. Place patient in Trendelenburg as tolerated to guide any residual helium to travel away from the head vessels. 4. Notify physician, and prepare for IAB catheter removal. 5. Consider IAB catheter replacement, if the patient s condition warrants. 6. If blood is suspected of having entered the pump, take pump out of service. It should be evaluated before use in another patient by a Getinge or Biomed/Technical Service representative who has been trained on Cardiosave service requirements, to determine if replacement of contaminated components is necessary. " If blood is not detected, ensure that the IAB extender tubing is tightly connected to the IAB and the IABP. If appropriate, perform an Autofill by pressing and holding the IAB FILL key for 2 seconds, then press the START key to resume pumping. " If the patient is febrile or tachycardic, consider increasi

Recall details

Recall number

Z-2435-2023

Status

Open, Classified

Initiated by the company

Jul 31, 2023

Posted by the FDA

Aug 30, 2023

Recalling firm

Datascope Corp.

Quantity

9175 units

Product code

DSP

FDA submissions

K181122

Distribution

Worldwide - US Nationwide distribution.

Product description

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65

Devices named in this recall

13 devices in the FDA device registry whose identifier appears in the recall's code information.

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

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls39 deaths10,316 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
• 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
• 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
• CARDIOSAVE HYBRID TYPE K PLUG 0998-00-0800-34

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

Other products in the same recall event

The FDA groups related products into one recall event (event 92491).

• Z-2436-2023 · Open, Classified
  Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85