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.
- Hazard
- unexpected-shutdown
- therapy-interruption
- capacitor-failure
Distribution
Distributed nationwide across the United States.
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