The Recall Desk
SevereFDA (Devices)·Z-2151-2023·Announced 2023-07-26

Cardiosave Hybrid Intra-Aortic Balloon Pump recalls due to unexpected device shutdown

Datascope has recalled Cardiosave Hybrid IABP models due to tantalum capacitor failures that may cause unexpected device shutdown, interrupting life-critical cardiac therapy.

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: FDA Class I classification with a critical-care cardiac device indicates serious risk requiring immediate attention. No deaths or injuries are reported in the source, preventing a Critical rating, but the potential for therapy interruption in a life-sustaining device warrants Severe.

Plain-English summary

Datascope Corp. is recalling the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) due to a manufacturing issue involving tantalum capacitors. The capacitors, located in the Power Management Board and/or Solenoid Board, may fail unexpectedly, causing the device to shut down without warning.

The recall affects 9,174 total units (4,586 in the U.S. and 4,588 internationally) across multiple model numbers: 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, and related UC variants. The devices were distributed worldwide to hospitals and medical facilities in the United States and more than 50 foreign countries.

When an unexpected shutdown occurs, the intra-aortic balloon pump may interrupt therapy, potentially affecting patients who depend on the device for cardiac support.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 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
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support / Intra-Aortic Balloon Pump
Hazard
  • unexpected-shutdown
  • therapy-interruption
  • capacitor-failure

Distribution

Distributed nationwide across the United States.

Related recalls

Same category