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MAQUET CARDIOHELP recallZ-1831-2024 · Maquet Medical Systems USA · initiated Apr 15, 2024

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

The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.

FDA root cause category: Under Investigation by firm

What the company is doing

Consignees received an "URGENT MEDICAL DEVICE - Removal" email, dated 4/15/2024, notifying them of this recall event. Consignees are asked to examine their inventory to identify if they possess any affected devices and all consignees are asked to return the provided Response Form via email to identify where affected devices are located. Consignees that report having any affected devices will be contacted by Getinge to arrange for return of the affected device to upgrade the system's sensor panel and perform testing to ensure that leakage current is within specifications. Technical Support can also be contacted at 888-943-8872 (option 4, option 2, option 1) Monday through Friday between 8:00 AM and 6:00 PM EST to make service arrangements. Consignees are asked to not use affected devices for any additional patients until it has been cleared by the MCP/Getinge system check, repaired, or replaced. The provided recall notice is to be forwarded to users of the CARDIOHELP-i system and if the device was further distributed.

Recall details

Recall number
Z-1831-2024
Status
Open, Classified
Initiated by the company
Apr 15, 2024
Posted by the FDA
May 16, 2024
Recalling firm
Maquet Medical Systems USA
Quantity
148 units (US: 5; OUS: 143)
Product code
DTQ
FDA submissions
K133598
Distribution
US Nationwide distribution in the states of NJ & TX.

Product description

CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Part No. 70104.8012 and 70104.8012R; UDI-DI: 04037691658384; Serial no. 90410021, 90410029, 90410165, 90410254, 90410255, 90410024, 90410025, 90410026, 90410028, 90410030, 90410031, 90410034, 90410035, 90410036, 90410043, 90410044, 90410045, 90410046, 90410047, 90410048, 90410049, 90410050, 90410051, 90410052, 90410053, 90410054, 90410055, 90410056, 90410057, 90410058, 90410059, 90410060, 90410061, 90410062, 90410063, 90410064, 90410065, 90410067, 90410068, 90410069, 90410070, 90410071, 90410072, 90410073, 90410074, 90410075, 90410076, 90410077, 90410078, 90410079, 90410080, 90410081, 90410082, 90410084, 90410085, 90410086, 90410087, 90410088, 90410089, 90410091, 90410093, 90410094, 90410095, 90410096, 90410097, 90410098, 90410099, 90410100, 90410101, 90410102, 90410103, 90410104, 90410105, 90410106, 90410107, 90410108, 90410109, 90410110, 90410111, 90410112, 90410113, 90410114, 90410115, 90410116, 90410117, 90410118, 90410119, 90410120, 90410121, 90410122, 90410123, 90410124, 90410125, 90410126, 90410127, 90410130, 90410131, 90410132, 90410133, 90410134, 90410135, 90410136, 90410137, 90410138, 90410139, 90410140, 90410141, 90410142, 90410143, 90410144, 90410146, 90410147, 90410148, 90410149, 90410151, 90410152, 90410153, 90410154, 90410155, 90410156, 90410157, 90410158, 90410159, 90410160, 90410161, 90410162, 90410163, 90410166, 90410167, 90410168, 90410169, 90410170, 90410172, 90410173, 90410174, 90410175, 90410176, 90410177, 90410178, 90410179, 90410180, 90410181, 90410182, 90410183, 90410184, 90410185, 90410186, 90410187.

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

4 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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