Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to a Safety Disk that may not meet performance requirements, potentially reducing IAB inflation during therapy. Affected units include model numbers 0998-00-0800-31 through 0998-00-0800-65 and associated serial numbers.
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Datascope is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers because the Safety Disk may not meet performance requirements. This could lead to slightly reduced inflation of the balloon during therapy or less effective augmentation of blood flow to the patient.
The Safety Disk in the pump may not meet performance requirements, which could cause slightly reduced inflation of the balloon during therapy. This might result in less effective augmentation of blood flow to the patient, but it does not pose an immediate risk of serious injury.
Healthcare professionals who use Cardiosave Hybrid Intra-Aortic Balloon Pumps with the listed model numbers and serial codes are most at risk. Patients using these devices during critical care may experience reduced therapy effectiveness.
Check for model numbers 0998-00-0800-31 through 0998-00-0800-65 on the pump's label. Also, verify the serial numbers listed in the recall notice, which include a range of codes starting with CB355244F2 and ending with CH354743F2.
Identify the model number on the pump's label to see if it matches the recalled range: 0998-00-0800-31 to 0998-00-0800-65.
Check the pump's serial number against the list provided in the recall notice, which includes codes starting with CB355244F2 and ending with CH354743F2.
The affected model numbers are 0998-00-0800-31 through 0998-00-0800-65.
Check the model number on the pump's label and compare it to the range 0998-00-0800-31 to 0998-0:00-0800-65. Also, verify the serial number against the list of codes starting with CB355244F2 and ending with CH354743F2.
The recall does not specify a remedy, so contact Datascope Corp. for further instructions.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1276-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1276-2023 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.
