Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly
The Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly when blood enters the device through a compromised balloon catheter during use.
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 mandates a minimum severity of Severe. The device may shut down unexpectedly during therapy, with no reported deaths or injuries documented.
Plain-English summary
The Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), manufactured by Datascope Corp., is being recalled because the device may shut down unexpectedly when blood enters it during therapy if the intra-aortic balloon catheter is compromised. Unexpected shutdown during therapy could disrupt the cardiac support being provided.
The recall affects 11,906 total units of the Cardiosave Hybrid IABP distributed worldwide, including throughout the United States and internationally. Affected devices span multiple models in the 0998-00-0800 and 0998-UC-0800 series.
Healthcare facilities using affected devices should verify their equipment using the provided model numbers. Report any unexpected shutdowns or device malfunctions to Datascope Corp. and the FDA.
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, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31…
- Manufacturer
- Datascope Corp.
- Affected units
- 11,906
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 0998-00-0800-31
- 10607567109053
- 0998-00-0800-32
- 10607567111117
- 0998-00-0800-33
- 0998-00-0800-34
- 10607567111940
- 0998-00-0800-35
- 10607567109107
- 0998-00-0800-36
- 10607567114187
- 0998-00-0800-45
- 10607567108421
- 0998-00-0800-52
- 10607567108438
- 0998-00-0800-53
- 10607567108391
- 0998-00-0800-55
- 10607567108414
- 0998-00-0800-65
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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