Skip to content

MAQUET CARDIOHELP recallZ-0595-2024 · Maquet Medical Systems USA · initiated Nov 14, 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

CARDIOHELP-i System was not properly tested to measure leakage current

FDA root cause category: Process design

What the company is doing

Maquet Cardiopulmonary GmbH (MCP)/Getinge issued Urgent Medical Device Correction Letter to U.S, consignees November 14, 2023 via FedEx. 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. " 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 4) 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 1-800-530-6084. " If you report having any affected CARDIOHELP-i devices, a local Getinge representative will contact you to arrange a system check of the device to ensure that leakage current is within specifications. " Affected CARDIOHELP-i devices are not requested to be returned and can be used as usual. " 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. Type of Action by Getinge: Getinge has identified the issue to be related to a supplier using an incorrect drawing to produce a tool used to measure leakage current of the CARDIOHELP-i. This issue has been corrected by the supplier. MCP/Getinge will contact you to arrange for a MCP/Getinge service technician to perform a system check of any affected device you report to confirm leakage current is within specifications (IEC 62353). If a system fails the performed test, the MCP/Getinge service technician will replace the system s sensor panel for you. MCP/Getinge service may have already performed the required system check of your device during a past preventative maintenance. MCP/Getinge will check service records to confirm. MCP

Recall details

Recall number
Z-0595-2024
Status
Open, Classified
Initiated by the company
Nov 14, 2023
Posted by the FDA
Sep 30, 2024
Recalling firm
Maquet Medical Systems USA
Quantity
1594 units
Product code
DTQ
FDA submissions
K133598
Distribution
Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iran, Islamic Republic Of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Macao, Maldives, Martinique, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom,Vietnam, Yemen

Product description

CARDIOHELP-i Heart Lung Support System: 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 (up to six hours). Product REF Numbers: 701072780; 701048012

Code information (models, lots, serial numbers)

UDI-DI: 04058863074863; 04037691658384 All serial numbers up to and including 90415172

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

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