Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential helium indicator inaccuracies 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 Hybrid Intra-Aortic Balloon Pump models because the helium indicator might show more helium than actually present when exposed to electromagnetic interference. This could lead to incorrect pump settings during medical use.
The helium indicator on the pump may show higher helium levels than actually present when electromagnetic interference occurs. This could cause incorrect pump settings during medical procedures, potentially affecting patient safety.
Healthcare professionals using Cardiosave IABP pumps with the listed model numbers are affected. Patients using these pumps are at risk if the helium indicator gives inaccurate readings.
Check for model numbers 0998-00-0800-31 through 0998-00-0800-65 on the pump. All lots of these models are included in the recall.
Identify the model number on your pump to see if it matches the recalled list.
The helium indicator may overestimate helium levels when exposed to electromagnetic interference, which could lead to incorrect pump settings during medical use.
Check the model number against the recalled list. If it matches, contact Datascope for further instructions.
The recall record does not mention a specific remedy or fix.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0075-2022 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0075-2022 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.
