Recall Z-3145-2026

Maquet Cardiopulmonary Gmbh · initiated July 31, 2026

Open, Classified

Product

Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);

Codes / lots: Model Number (USA): 701053069; UDI-DI: 4037691730677; Lot Numbers: 3000324478, 3000326922, 3000336965, 3000339840, 3000347863, 3000370471, 3000374104, 3000379854, 3000382443, 3000395582, 3000403657, 3000414517, 3000430804, 3000434603, 3000444269, 3000445982, 3000453327, 3000466026, 3000471522, 3000476322, 3000476324, 3000479560, 3000485154, 3000491022, 3000496205, 3000503935, 3000510431, 3000511851, 3000518007, 3000520749, 3000525464, 3000528231, 3000534008; Model Number (OUS): 701047385; UDI-DI: 4037691519876; Lot Numbers: 3000324481, 3000324482, 3000324483, 3000326924, 3000326926, 3000326927, 3000326928, 3000328824, 3000328825, 3000328826, 3000328827, 3000328828, 3000331194, 3000331195, 3000331196, 3000331197, 3000331198, 3000331199, 3000331225, 3000333814, 3000333815, 3000333816, 3000333817, 3000333818, 3000334775, 3000334776, 3000334777, 3000334778, 3000334779, 3000336028, 3000336029, 3000336030, 3000336031, 3000336032, 3000336033, 3000338092, 3000338093, 3000338094, 3000338095, 3000338096, 3000339833, 3000339834, 3000339835, 3000339836, 3000339837, 3000341453, 3000341454, 3000341455, 3000341456, 3000342415, 3000342416, 3000342417, 3000342418, 3000342419, 3000342420…

Reason for recall

The packaging may not consistently maintain sterile barrier integrity.

FDA-determined cause: Packaging

Action taken

On July 31, 2026 URGENT MEDICAL DEVICE REMOVAL letters were sent to customers. Customer Actions: 1. Ensure all affected, unused product in your inventory has been properly quarantined. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 3. Contact Customer Service via email at customersupport.us@getinge.com or 888-943-8872, option 2 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone) to return your unused, unexpired, affected product. Credit will be issued for returned product. 4. Complete and return the enclosed response form to Getinge by e-mailing a copy to recallresponses.qrc@getinge.com.

Details

Recall number
Z-3145-2026
Initiated
July 31, 2026
Posted by FDA
September 11, 2026
Product code
DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Quantity
185617 units (5926 US, 179691 OUS)
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates…
Recalling firm
Maquet Cardiopulmonary Gmbh, Rastatt

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-3144-2026 Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA)…The packaging may not consistently maintain sterile barrier integrity. 07/31/2026Open, Classified
Z-3146-2026 Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA)…The packaging may not consistently maintain sterile barrier integrity. 07/31/2026Open, Classified