Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model… recallZ-0885-2023 · Datascope Corp. · initiated Dec 19, 2022

Why it was recalled

The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.

FDA root cause category: Device Design

What the company is doing

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 12/19/2022 was sent to customers. It contains clinical guidance to augment current clinical recommendations of patient management strategies should an IAB perforation occur. Maintain established patient and device management strategies regarding timing to IAB catheter removal. User Actions to be taken include to examine inventory immediately to determine if affected units are on hand, if a blood back event is suspected, remove the Cardiosave from patient use, and report the event to appropriate biomedical engineering staff for inspection prior to next patient use, and ensure that all Cardiosave Intra-Aortic Balloon Pump users at your facility are aware of this notice. Customers were also instructed to sign and return the MEDICAL DEVICE CORRECTION - RESPONSE FORM and notify customers if affected units were further distributed. The Cardiosave IABP units distributed going forward will be added to the scope and newly affected consignee(s) will be notified of the field correction. Letter dated 11/21/23 titled THIS IS AN UPDATE TO THE PREVIOUSLY INITIATED ACTION URGENT MEDICAL DEVICE CORRECTION was sent to customers. This notification is an update to the previously initiated action, dated December 19, 2022, regarding potential for blood to enter into the Cardiosave Hybrid and Rescue IABPs. The update is primarily to share new recommendations, such as a new labeling addendum and to consider the benefits and risks of using Cardiosave IABP on a patient during transport. Instructions were the same as the first letter. Updated letters will be sent to OUS consignees, beginning on 07/31/2025 alerting consignees of an upcoming component correction and software update to resolve the previous issues. Letters will be distributed as approval is received for each country. Once approval is received in the US, US consignees will be notified.

Recall details

Recall number

Z-0885-2023

Status

Open, Classified

Initiated by the company

Dec 19, 2022

Posted by the FDA

Jan 19, 2023

Recalling firm

Datascope Corp.

Quantity

11,906 Total

Product code

DSP

FDA submissions

K181122

Distribution

Worldwide Distribution - US Nationwide and the countries of Albania, Angola, Argentina, Australia, Austria, AZERBAIJAN, BAHRAIN, BANGLADESH, Barbados, Belarus, Belgium, BOSNIA and HERZEGOVINA, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d'Ivoire, Croatia, CZECH REPUBLIC, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, TRINIDAD AND TOBAGO, Tunisia, Turkey, Turkmenistan, Ukraine, UNITED ARAB EMIRATES, United Kingdom, Vietnam, Yemen, and Zambia.

Product description

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-32, 0998-UC-0800-33, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55, 0998-UC-0800-65.

Devices named in this recall

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

• CARDIOSAVE HYBRID, TYPE B PLUG 0998-00-0800-53

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls39 deaths10,316 reports
• CARDIOSAVE HYBRID W/ E/F PLUG 0998-00-0800-55

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls8 deaths1,686 reports
• CARDIOSAVE HYBRID, TYPE I PLUG 0998-00-0800-45

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls5 deaths1,181 reports
• CARDIOSAVE HYBRID, TYPE G PLUG 0998-00-0800-52

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls2 deaths1,157 reports
• CARDIOSAVE HYBRID, 3.1 EDITION 0998-00-0800-65

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls3 deaths456 reports
• CARDIOSAVE HYBRID TYPE I (AU) 0998-00-0800-31

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls232 reports
• CARDIOSAVE HYBRID TYPE D PLUG 0998-00-0800-33

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls2 deaths230 reports
• CARDIOSAVE HYBRID TYPE J PLUG 0998-00-0800-32

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls2 deaths48 reports
• CARDIOSAVE HYBRID TYPE M PLUG 0998-00-0800-35

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls13 reports
• CARDIOSAVE HYBRID TYPE K PLUG 0998-00-0800-34

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  15 recalls0 reports
• CARDIOSAVE HYBRID - TYPE "N" PLUG 0998-00-0800-36

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  9 recalls1 death16 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 91179).

• Z-0886-2023 · Open, Classified
  Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.