Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pump models 0998-00-0800-75, 83, 85 due to helium indicator potentially overestimating helium levels in electromagnetic interference.
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
Datascope is recalling specific Cardiosave Rescue Intra-Aortic Balloon Pump models because the helium indicator might show more helium than actually present when electromagnetic interference occurs. This could lead to incorrect pump settings during medical use.
The helium indicator on the Cardiosave display may show higher helium levels than actually present when electromagnetic interference occurs. This could cause the pump to operate incorrectly during medical procedures, potentially affecting patient safety.
Healthcare professionals using the Cardiosave IABP models 0998-00-0800-75, 83, 85 are likely affected. Patients receiving this device during medical procedures are at risk if the helium indicator gives inaccurate readings.
Check for Cardiosave Rescue Intra-Aortic Balloon Pump models 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85. All lots of these models are included in the recall.
Verify the model number on your Cardiosave Rescue Intra-Aortic Balloon Pump to see if it matches the recalled models 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.
The helium indicator on the Cardiosave display may overestimate the amount of helium present in the unit when electromagnetic interference occurs, which could lead to incorrect pump settings during medical procedures.
The recall does not specify a remedy, so you should check the model number to see if it is affected. If it is, contact Datascope for further instructions.
The recall states the helium indicator may overestimate helium levels, but it does not mention a risk of serious injury. The hazard level is low risk.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0076-2022 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0076-2022 from Datascope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
