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MAQUET CARDIOHELP recallZ-0555-2024 · Maquet Medical Systems USA · initiated Nov 6, 2023

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 Maquet Medical Systems USA 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

Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp

FDA root cause category: Labeling design

What the company is doing

Maquet Cardiopulmonary GmbH (MCP)/Getinge issued Urgent Medical Device- Correction Customer Letter to US consignees issued on 11/6/23 via express mail. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any affected CARDIOHELP-i in your inventory. " Please review, download, and print the updated IFU for these products at: https://us.getinge.com/l/950532/2023-10-13/ppb1d2 " Please remove and destroy any previous versions of the IFU at your facility. " As noted in the Key User Functions section of the IFU: " Before beginning the application, ensure that the selected warning and alarm limits, as well as interventions, are suitable and safe for the patient and the current situation. " Before beginning the application, check every intervention selected by simulating an alarm condition. " Should you have any questions or need additional copies of the IFU, please contact Getinge Customer Support at (888) 943-8872 (select option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). " Please forward this information to all current and potential CARDIOHELP-i 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. Whether or not your facility has affected product(s) listed in this notice, 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 Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1- 800-861-0842. Type of Action by Getinge: The corrected IFU for the CARDIOHELP-i Heart Lung Support System is available at the web link included in this letter. Getinge will also send a hard copy of the IFU to those customers who request one.

Recall details

Recall number
Z-0555-2024
Status
Open, Classified
Initiated by the company
Nov 6, 2023
Posted by the FDA
Dec 14, 2023
Recalling firm
Maquet Medical Systems USA
Quantity
1595 units
Product code
DTQ
FDA submissions
K133598
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Brunei, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Maldives, Martinique, Mauritius, Mayotte, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Republic of Korea, R¿union, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.

Product description

CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)

Code information (models, lots, serial numbers)

UDI Code: 04058863074863 (CARDIOHELP-I US); 04037691658384 (CARDIOHELP-I NONUS). All serial numbers up to and including 90415177.

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

3 devices cleared under K133598 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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