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Cardiosave Hybrid IABP - Product Usage: used to inflate and… recallZ-1506-2021 · Datascope Corp. · initiated Mar 22, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Datascope Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).

FDA root cause category: Software design

What the company is doing

URGENT MEDICAL DEVICE CORRECTION notification letters dated 3/22/21 were distributed to customers. PLEASE FORWARD THIS INFORMATION TO ALL CURRENT AND POTENTIAL CARDIOSAVE HYBRID and CARDIOSAVE RESCUE IABP USERS WITHIN YOUR HOSPITAL / FACILITY. IF YOU ARE A DISTRIBUTOR WHO HAS SHIPPED ANY AFFECTED PRODUCTS TO CUSTOMERS, PLEASE FORWARD THIS DOCUMENT TO THEIR ATTENTION FOR APPROPRIATE ACTION. Corrective Action: Datascope/Getinge is currently developing a software correction to address this issue. A Datascope/Getinge service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility. Please complete and sign the attached MEDICAL DEVICE CORRECTION RESPONSE FORM (page 5) to acknowledge that you have received this notification. Return the completed form to Datascope/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1-800-506-1644.

Recall details

Recall number
Z-1506-2021
Status
Open, Classified
Initiated by the company
Mar 22, 2021
Posted by the FDA
Apr 28, 2021
Recalling firm
Datascope Corp.
Quantity
10087 total
Product code
DSP
FDA submissions
K112372, K151254, K163542
Distribution
Worldwide distribution - US Nationwide distribution.

Product description

Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

Code information (models, lots, serial numbers)

All Systems. UDI: 10607567111117 10607567109008 10607567111940 10607567109107 10607567108421 10607567108438 10607567108391 10607567108414 10607567113432

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 87482).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page