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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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*…
- Manufacturer
- Datascope Corp.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Datascope Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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