Cardiosave Rescue IABP Alarms May Trigger Unexpectedly During Therapy
Datascope Corp. is recalling approximately 9,175 Cardiosave Rescue IABPs because unexpected gas-loss and gas-gain alarms may occur during therapy due to patient movement, blood in the circuit, and hardware issues.
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 medical device recall. Per the rubric, FDA Class I recalls require a minimum severity score of 4.
Plain-English summary
Datascope Corp. is recalling approximately 9,175 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) units distributed worldwide, including throughout the United States. The recall affects all lot numbers and includes Part Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85.
The recall was initiated after users reported instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms occurring during therapy. An internal investigation determined that these alarms can be triggered by factors not listed in the device instructions for use, including patient movement (coughing, general movement, and swallowing), blood in the circuit, kinks or abrasions of the tubing or catheter, and certain patient conditions. The manufacturer also identified hardware issues related to these alarms.
The U.S. Food and Drug Administration (FDA) assigned this a Class I classification, the most serious type of medical device recall.
The recalled product
- Product
- Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- Manufacturer
- Datascope Corp.
- Category
- Medical Device
- Hazard
- unexpected-alarm
- hardware-defect
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 (6)
- All Lot Numbers. Model: 0998-00-0800-75
- UDI: 10607567112312
- Model: 0998-00-0800-83
- UDI: 10607567108407
- Model: 0998-00-0800-85
- UDI: 10607567113449
Distribution
Distributed nationwide across the United States.
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