www.fda.gov Open in urlscan Pro
2a02:26f0:ab00:384::308a  Public Scan

Form analysis
1 forms found in the DOM

Name: searchForm — GET /search

<form class="fda-masthead__search sr-only" role="search" action="/search" method="GET" name="searchForm" id="search-form" accept-charset="UTF-8">
  <div class="search-popover" id="search-popover">
    <div class="input-group pull-right" id="search-group">
      <label class="sr-only" for="search-query">Search FDA</label>
      <input class="form-control search-input" id="search-query" name="s" aria-autocomplete="list" aria-haspopup="true" title="Enter the terms you wish to search for." placeholder="Search FDA" type="text">
      <span class="input-group-btn" id="input-group-btn">
        <button type="submit" class="btn btn-danger search-btn" id="search-btn" title="Search"><span class="fa fa-search" aria-hidden="true"><span class="sr-only">Submit search</span></span></button>
      </span>
    </div>
  </div>
</form>

Text Content

 * Skip to main content
 * Skip to FDA Search
 * Skip to in this section menu
 * Skip to footer links

An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive
information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that
any information you provide is encrypted and transmitted securely.


U.S. FOOD AND DRUG ADMINISTRATION

 *   Search
 *   Menu

Search FDA Submit search


FEATURED

 * Report a Product Problem
 * Contact FDA
 * FDA Guidance Documents
 * Recalls, Market Withdrawals and Safety Alerts
 * Press Announcements
 * Warning Letters
 * Advisory Committees
 * En Español


PRODUCTS

 * Food
 * Drugs
 * Medical Devices
 * Radiation-Emitting Products
 * Vaccines, Blood, and Biologics
 * Animal and Veterinary
 * Cosmetics
 * Tobacco Products


TOPICS

 * About FDA
 * Combination Products
 * Regulatory Information
 * Safety
 * Emergency Preparedness
 * International Programs
 * News and Events
 * Training and Continuing Education
 * Inspections and Compliance
 * Science and Research


INFORMATION FOR

 * Consumers
 * Patients
 * Industry
 * Health Professionals
 * Federal, State and Local Officials


In this section: Letters to Health Care Providers
 * Letters to Health Care Providers
    * 2024 Letters to Health Care Providers
    * 2023 Letters to Health Care Providers
    * 2022 Letters to Health Care Providers
   
   

 1. Home
 2. Medical Devices
 3. Medical Device Safety
 4. Letters to Health Care Providers
 5. Safety and Quality Concerns with Getinge Cardiovascular Devices - Letter to
    Health Care Providers

 1. Letters to Health Care Providers


SAFETY AND QUALITY CONCERNS WITH GETINGE CARDIOVASCULAR DEVICES - LETTER TO
HEALTH CARE PROVIDERS

 * Share
 * Post
 * Linkedin
 * Email
 * Print



May 8, 2024

The U.S. Food and Drug Administration (FDA) is alerting health care providers
and facilities about our continued safety and quality concerns with the
following Getinge/Maquet cardiovascular medical devices:

 * Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon
   Pump (IABP) devices and
 * Getinge/Maquet Cardiohelp system and HLS Sets.

The FDA recommends that health care facilities transition away from use of these
devices and seek alternatives, if possible. These recommendations are based on
our continued concerns that Getinge/Maquet has not sufficiently addressed the
problems and risks with these recalled devices. 

The FDA continues to receive medical device reports (MDR) related to the
problems even though Getinge/Maquet took corrective steps, including reinforcing
information in the Instructions for Use as well as providing users with new
actions they should take when using the IABP. 

The FDA recognizes that alternative treatment options are limited and has
provided the recommendations below for health care providers when these Getinge
cardiovascular devices are used. 


RECOMMENDATIONS

 * Plan for alternative capital equipment to transition away from these Getinge
   cardiovascular devices: 
   * Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon
     Pump (IABP) devices.
   * Getinge Cardiopulmonary bypass (CPB) devices including the Getinge/Maquet
     Cardiohelp system and HLS Sets.
 * Use alternative devices, if possible. If you don’t have alternatives and
   continue to use these devices:
   * Review the FDA’s previous recommendations. Read any Urgent Medical Device
     Correction notices from Getinge and follow the recommendations. 
   * Be aware of the recalls related to these devices.
 * Report any issues or adverse events with Getinge devices to the FDA. For
   details on reporting, see Reporting Problems to the FDA.
 * Report any supply chain issues to the deviceshortages@fda.hhs.gov mailbox.


BACKGROUND

CARDIOSAVE HYBRID AND RESCUE IABP

The Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue IABP is a cardiac
assist device placed in the artery that is in the chest and abdomen (descending
aorta). The device is an electromechanical system used to inflate and deflate
intra-aortic balloons. These systems provide temporary support to the heart's
left ventricle through counter pulsation.  

 * CARDIOSAVE RECALLS AND MDRS
   
   * From January 1, 2023 through April 11, 2024, Getinge initiated 12 voluntary
     recalls in the U.S. for the Cardiosave IABP. Of these, the FDA classified
     eight as a Class I recall, the most serious type of recall. In the last 12
     months, the FDA has received 2,964 medical device reports (MDR) related to
     Cardiosave Intra-Aortic Balloon Pumps.  Of those, 15 were reported as
     resulting in patient serious injury or death. As a general matter, MDRs are
     one of the FDA’s several postmarket surveillance tools used to monitor
     device performance, detect potential device-related safety issues, and
     contribute to benefit-risk assessments during real world use. It may be
     difficult to confirm a direct cause and effect between an adverse event
     report and a specific medical device based on the limited information
     provided in the reports.
   * The FDA continues to receive adverse event reports related to the failures
     associated with Cardiosave recalls. Since 2017, the FDA has been evaluating
     and monitoring MDRs that describe Cardiosave IABP devices shutting down.
     The FDA has also been evaluating other concerns with the Cardiosave IABP,
     including blood entering the device, which can cause the IABP to rupture
     (helium emboli) or the patient or health care provider being exposed to
     patient blood. 
   * In addition, on March 1, 2024External Link Disclaimer, TÜV SÜD, the
     European Union notified body for certification services, temporarily
     suspended the CE certificate (CE marking means that products have
     Conformité Européenne or European conformity certification) for Getinge’s
     Cardiosave Intra-Aortic Balloon Pump with immediate effect.  Getinge is
     given six months to adhere to the required corrective actions, and during
     this time, the Intra-Aortic Balloon Pumps cannot be sold in countries that
     require CE certification.  This only impacts the Cardiosave devices. 

CARDIOHELP SYSTEM AND HLS SETS

The Getinge/Maquet Cardiohelp system is a cardiopulmonary bypass device that
pumps blood out of the patient to oxygenate the blood during cardiopulmonary
bypass surgeries.  It can be used for up to six hours. The HLS Set is an
oxygenator and blood pump, which is a disposable component of the Cardiohelp
system.

 * CARDIOHELP AND HLS SET RECALLS AND MDRS
   
   * From January 1, 2023, through April 11, 2024, Getinge initiated eight
     voluntary recalls for the Cardiohelp system, including the HLS Set.  Of
     these, the FDA classified one as a Class I recall, the most serious type of
     recall. In the last 12 months, the FDA received 246 MDRs related to the
     Getinge Cardiohelp System, including the HLS Set.  Of those, 33 were
     reported as resulting in patient serious injury or death. However, as
     stated above it may be difficult to confirm a direct cause and effect
     between an adverse event report and a specific medical device based on the
     limited information provided in the reports. The FDA continues to have
     concerns regarding the sterility of the HLS Set. 
   * Sterility was also a concern in May 2023, when Getinge notified U.S.
     customers that it removed another of its cardiopulmonary bypass devices,
     the Quadrox oxygenators, from the U.S. market. The Quadrox oxygenators
     continue to be unavailable because of sterility issues. 


FDA ACTIONS

The FDA continues to work with the Getinge to understand factors contributing to
the device failures, as well as possible mitigation strategies.

The FDA is working with other manufacturers to assess their interest and ability
to manufacture and distribute alternative devices in the U.S.

The FDA worked with the U.S. Department of Justice to place Getinge
manufacturing sites under consent decree in 2015 and added the IABP
manufacturing site in 2022.  This action allows additional FDA oversight, an
independent auditor, inspections, and updates on progress made toward addressing
quality and safety concerns. At this time, the cardiopulmonary bypass and IABP
facilities have not met the requirements to have the consent decree lifted.

The FDA will continue to keep health care providers and the public informed if
new or additional information becomes available.


PREVIOUS FDA COMMUNICATIONS

 * UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave
   Intra-Aortic Balloon Pump (IABP) – Letter to Health Care Providers  
 * Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility
   with HLS Set Advanced - Letter to Health Care Providers  
 * Oxygenator Devices Used for Extracorporeal Circulation - Letter to Health
   Care Providers 


UNIQUE DEVICE IDENTIFIER (UDI)

The FDA established the unique device identification system to adequately
identify medical devices sold in the United States from manufacturing through
distribution to patient use. For more information on UDI, please visit Unique
Device Identification System (UDI Systems). 


REPORTING PROBLEMS TO THE FDA

If you are experiencing supply issues, contact the FDA about a medical device
supply chain issue. Reporting supply issues informs the FDA of how it may be
able to help address device supply availability. 

The FDA encourages health care providers to report any adverse events or
suspected adverse events experienced with the Getinge devices. 

 * You can submit voluntary reports through MedWatch, the FDA Safety Information
   and Adverse Event Reporting program.
 * Device manufacturers and user facilities must comply with the applicable
   Medical Device Reporting (MDR) regulations.
 * Health care personnel employed by facilities that are subject to the FDA's
   user facility reporting requirements should follow the reporting procedures
   established by their facilities.

By promptly reporting adverse events, you can help the FDA identify and better
understand the risks associated with medical devices.


CONTACT INFORMATION

If you have questions about this letter, contact the Division of Industry and
Consumer Education (DICE).


 
Was this helpful?
YesNo


 * CONTENT CURRENT AS OF:
   
   05/08/2024


 * REGULATED PRODUCT(S)
   
    * Medical Devices

 * Letters to Health Care Providers
    * 2024 Letters to Health Care Providers
    * 2023 Letters to Health Care Providers
    * 2022 Letters to Health Care Providers
   
   




FOOTER LINKS

 * FDA Archive
 * About FDA
 * Accessibility

 * Visitor Information
 * Website Policies / Privacy
 * No FEAR Act
 * Vulnerability Disclosure Policy

 * FOIA
 * HHS.gov
 * USA.gov

Contact FDA Follow FDA on Facebook Follow FDA on X Follow FDA on Instagram
Follow FDA on LinkedIn View FDA videos on YouTube Subscribe to FDA RSS feeds
FDA Homepage
Contact Number 1-888-INFO-FDA (1-888-463-6332)

Back to Top