Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-08

FDA device recall Z-0336-2022 · posted 2021-12-30 · Open, Classified

Recall details

Recalling firm

Datascope Corp.

Reason for recall

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.

Action taken

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

Root cause

Device Design

Status

Open, Classified

Product code

DSP

Quantity affected

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

Distribution

Worldwide distribution - US Nationwide.

Date initiated

2021-11-15

Date posted

2021-12-30

Location

Mahwah, NJ

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