Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers:… recallZ-0336-2022 · Datascope Corp. · initiated Nov 15, 2021

Why it was recalled

Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.

FDA root cause category: Device Design

What the company is doing

On November 15, 2021, the firm issued an Urgent Medical Device Correction letter to all affected consignees which informed them that the exterior of the Cardiosave Hybrid and Rescue IABP may be susceptible to fluid ingress at specific locations on the device. IABPs contain various electronic circuit boards. Liquid spills, such as saline, can create bridges of resistance between the circuit components; causing the circuit to not function as intended. This can impact initiation or continuation of counterpulsation therapy. Datascope/Getinge had previously issued an Urgent Medical Device Correction letter on April 26, 2018 to install a Top Protective Cover for the Cardiosave Hybrid IABP to help reduce the potential for fluid ingress. However, in some instances and depending on the volume of spill, this Top Protective Cover can overflow and fluid can enter the device in other susceptible areas. Consignees were requested to immediately examine inventory to determine if there is affected product on hand and that a correction should be available in 2022. Consignees were advised that in the meantime, continue to follow the IFU and adhere to the instructions when using the Cardiosave Hybrid and/or Rescue IABP In the unlikely event that a sudden interruption of therapy occurs, transfer the patient to an alternative IABP. If an alternative IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate, repeat every 5 minutes until either an alternate IABP is available or alternatively, the intra-aortic balloon catheter should be removed from the patient. The Intra-Aortic Balloon (IAB) Catheter Instructions for Use reinforces that the IAB catheter should not remain inactive (i.e. not inflating and deflating) for more than 30 minutes because of the potential for thrombus formation. Consignees were requested to forward this information to all current and potential affected. Distributors were also requested to forward the letter to customer atte

Recall details

Recall number

Z-0336-2022

Status

Open, Classified

Initiated by the company

Nov 15, 2021

Posted by the FDA

Dec 30, 2021

Recalling firm

Datascope Corp.

Quantity

5,566 (US); 6,354 (OUS)

Product code

DSP

FDA submissions

K112372, K151254, K163542

Distribution

Worldwide distribution - US Nationwide.

Product description

Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45, 0998-UC-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, 0998-UC-0800-65.

Devices named in this recall

11 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 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 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
• CARDIOSAVE HYBRID - TYPE "N" PLUG 0998-00-0800-36

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

Other products in the same recall event

The FDA groups related products into one recall event (event 88983).

• Z-0337-2022 · Open, Classified
  Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.