Class II U.S. Food and Drug Administration

Datascope Corp. Cardiosave Rescue. Intra-Aortic Balloon Pump system recall: The IFU addendum revises the Preventative Maintenance schedule to align

Recall published 10 months ago

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

The hazard

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Recall details

Recall number
Z-0917-2026
Published
December 17, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Datascope Corp.
Product type
Medical devices
Units affected
47 units
Distribution
Nationwide
Made in
United States
Lot / code info
Model No. (UDI): 0998-00-0800-83 (10607567108407); ALL SERIAL NO.

Products covered by this recall

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

What this device recall means for you

Most device recalls are corrections rather than removals: the product stays in use and the manufacturer issues updated instructions, a software patch or a replacement part. Check which applies before you change anything.

  1. Match the model, catalogue and lot numbers above against the label on your device or its packaging.
  2. If the device is implanted or you depend on it daily, do not remove, disable or stop using it before speaking to your clinician. The notice above explains the specific failure mode they need to know about.
  3. If you are a clinician or facility, quarantine affected stock, check whether the manufacturer has issued a field correction, and work through your usual recall log.
  4. Home users should contact the supplier who provided the device — a hospital, DME company or online retailer — as they hold the serial-number records needed to action the recall.
  5. Problems with a device can be reported to the FDA through MedWatch, which feeds the same enforcement database this page is built from.

Replacements, repairs and reimbursement

Device remedies are handled through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number shown on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free of charge by the manufacturer, who pays return shipping.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not be charged a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim will rest on.

Company contact: Datascope Corp. — 1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

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