Datascope recalls a specific low level output cable for cardiac pumps due to incorrect cable in packaging. Affected units may have safety risks.
One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.
Datascope is recalling a low level output cable used with certain cardiac pumps because it was shipped with the wrong cable. This could lead to improper function of the medical device.
The incorrect cable could cause improper function of the cardiac pump system. This might lead to incorrect monitoring or operation of the pump, potentially affecting patient safety.
Healthcare professionals using Cardiosave and CS30:00 intra-aortic balloon pumps with the specific cable model are most at risk. Patients using these pumps may be affected if the incorrect cable is installed.
Check for the part number 0012-00-1589-03 on the cable packaging. The cable is used with Cardiosave and CS300 intra-aortic balloon pumps.
Look for the part number 0012-00-1589-03 on the cable packaging to confirm if it is affected.
The recall is due to an incorrect cable being shipped, which could lead to improper function of the cardiac pump system. However, the hazard level is low risk as the remedy is limited to checking the packaging.
Check the packaging for the part number 0012-00-1589-03. This cable is used with Cardiosave and CS300 intra-aortic balloon pumps.
The recall does not specify a remedy, so check the packaging for the part number and contact Datascope if needed.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0266-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0266-2020 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.
