Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support
FDA device recall Z-1507-2021 · posted 2021-04-28 · Open, Classified
Recall details
- Recalling firm
- Datascope Corp.
- Reason for recall
- 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).
- Action taken
- 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 cardiosaveripple20.act@getinge.com or by faxing the form to 1-800-506-1644.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- DSP
- Quantity affected
- 10087 total
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Date initiated
- 2021-03-22
- Date posted
- 2021-04-28
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case (K163542) | Datascope Corp. | 2017-01-31 |
| CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (K151254) | Datascope Corp. | 2015-07-02 |
| CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (K112372) | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-15 |