ProductGuru Recalls

Official recall record

CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. (ref Z-3135-2024)

US FDA — Medical Devices · 2024-08-08 · United StatesClass I
Issuing authority
US FDA — Medical Devices
Alert date
2024-08-08
Country of alert
United States
Alert level
Class I
Alert type
recall
Barcode (EAN/GTIN)
10607567112312
Brand on record
Datascope Corp.
Product category
Medical Device

What the authority reported

Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 6 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

Other recalls from this brand

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.