The Recall Desk
SevereFDA (Devices)·Z-1147-2023·Announced 2023-03-15

Cardiosave Hybrid IABP Recalled for Risk of Unexpected Shutdown

The Cardiosave Hybrid intra-aortic balloon pump (IABP) is being recalled because it may unexpectedly shut down due to communication loss between internal components. The shutdown could interrupt therapy in cardiac patients and compromise their hemodynamic stability.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which designates the most serious category of medical device recalls and establishes a minimum severity level of 4. Although no reported injuries or deaths are mentioned, the risk of unexpected shutdown and interruption of critical life-supporting therapy in cardiac patients represents a serious potential threat to patient safety and hemodynamic stability.

Plain-English summary

The Cardiosave Hybrid intra-aortic balloon pump (IABP) is subject to an FDA Class I recall due to a potential device malfunction. Datascope Corp. has distributed 4,793 devices in the United States and 4,407 devices internationally.

The device may unexpectedly shut down due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. When this communication loss occurs, the IABP stops delivering therapy to the patient. The user may not immediately be aware that the device has shut down or that the patient's clinical status has been affected.

An unexpected interruption in therapy may threaten the hemodynamic stability of patients who depend on the IABP for cardiac support. Hemodynamic stability is essential for these patients, as the IABP helps maintain adequate blood circulation and heart function.

The recalled product

Product
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac support device
Hazard
  • unexpected-shutdown
  • communication-failure
  • therapy-interruption

Distribution

Distributed nationwide across the United States.

Related recalls

Same category