Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model… recallZ-3145-2026 · Maquet Cardiopulmonary Gmbh · initiated Jul 31, 2026
Open, Classified
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Maquet Cardiopulmonary Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
- 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 packaging may not consistently maintain sterile barrier integrity.
FDA root cause category: Packaging
What the company is doing
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 [email protected] 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 [email protected].
Recall details
- Recall number
- Z-3145-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 31, 2026
- Posted by the FDA
- Sep 11, 2026
- Recalling firm
- Maquet Cardiopulmonary Gmbh
- Quantity
- 185617 units (5926 US, 179691 OUS)
- Product code
- DWF
- FDA submissions
- K131666
- 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, United Kingdom;
Product description
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Code information (models, lots, serial numbers)
Show the full code information (7k characters)
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, 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3000404887, 3000404888, 3000404889, 3000404890, 3000406842, 3000406846, 3000406847, 3000406849, 3000408180, 3000408181, 3000408182, 3000408183, 3000408184, 3000408185, 3000410261, 3000410262, 3000410263, 3000410264, 3000411200, 3000412146, 3000412642, 3000412643, 3000413597, 3000413598, 3000413599, 3000413600, 3000414520, 3000414521, 3000414522, 3000414523, 3000414524, 3000417082, 3000417083, 3000417084, 3000417085, 3000417086, 3000417087, 3000418479, 3000418480, 3000418481, 3000418482, 3000420376, 3000420377, 3000420378, 3000423668, 3000423669, 3000423671, 3000423672, 3000423673, 3000424270, 3000424271, 3000424272, 3000424273, 3000424274, 3000425770, 3000425771, 3000425772, 3000425773, 3000431822, 3000431823, 3000431824, 3000431825, 3000431826, 3000431827, 3000431828, 3000434599, 3000434600, 3000434601, 3000434602, 3000438012, 3000438013, 3000441388, 3000441389, 3000441824, 3000444275, 3000444276, 3000444277, 3000444718, 3000444719, 3000444720, 3000444721, 3000445645, 3000445646, 3000445647, 3000445648, 3000445978, 3000445979, 3000445980, 3000445981, 3000448173, 3000448174, 3000448175, 3000448176, 3000448177, 3000449727, 3000449728, 3000449729, 3000449730, 3000451984, 3000451985, 3000451986, 3000451987, 3000451988, 3000453331, 3000453332, 3000455124, 3000455125, 3000455126, 3000455127, 3000458528, 3000458529, 3000458530, 3000458531, 3000458532, 3000461212, 3000461213, 3000461214, 3000461215, 3000461217, 3000464623, 3000464624, 3000464625, 3000464626, 3000466030, 3000466031, 3000466032, 3000466033, 3000468423, 3000468424, 3000468425, 3000471528, 3000471529, 3000471530, 3000471531, 3000471536, 3000471541, 3000471542, 3000471544, 3000475595, 3000475596, 3000475597, 3000477179, 3000477180, 3000477181, 3000478746, 3000478747, 3000478748, 3000478749, 3000478836, 3000479564, 3000479565, 3000479567, 3000481004, 3000481005, 3000481006, 3000481945, 3000481946, 3000481947, 3000481948, 3000484178, 3000484179, 3000484180, 3000484181, 3000485143, 3000486784, 3000486785, 3000486786, 3000488308, 3000488309, 3000488310, 3000489895, 3000489896, 3000490871, 3000490874, 3000491430, 3000491431, 3000491432, 3000491433, 3000493065, 3000493066, 3000493067, 3000493068, 3000496199, 3000496200, 3000496201, 3000496202, 3000496203, 3000498673, 3000498674, 3000498834, 3000501303, 3000501304, 3000501305, 3000501307, 3000502840, 3000502841, 3000502843, 3000502844, 3000503939, 3000503942, 3000503943, 3000510425, 3000510426, 3000510427, 3000511848, 3000511849, 3000511850, 3000513501, 3000513502, 3000513503, 3000513504, 3000513505, 3000514609, 3000514610, 3000514611, 3000514612, 3000515696, 3000515697, 3000515698, 3000515699, 3000517998, 3000518004, 3000518005, 3000519528, 3000519529, 3000519530, 3000519531, 3000519532, 3000520745, 3000520746, 3000520747, 3000520748, 3000522411, 3000522412, 3000522413, 3000522414, 3000522415, 3000523510, 3000523511, 3000524539, 3000524540, 3000524541, 3000525039, 3000525040, 3000525041, 3000525042, 3000525043, 3000525460, 3000525461, 3000525462, 3000525463, 3000526919, 3000526920, 3000526921, 3000526922, 3000528714, 3000528715, 3000528716, 3000530042, 3000530043, 3000530044, 3000530045, 3000534004, 3000534005, 3000534006, 3000535444, 3000535445, 3000535446, 3000535447, 3000537045, 3000537046, 3000537047, 3000537048, 3000539525, 3000539526, 3000539527, 3000539528, 3000541228, 3000541229, 3000541230, 3000541231, 3000541232, 3000543979, 3000543986, 3000543989, 3000547001, 3000547002, 3000547003, 3000547004, 3000549189, 3000549190, 3000549191, 3000550936, 3000550937, 3000550938, 3000550939, 3000553331, 3000553332, 3000553333, 3000553334, 3000553335, 3000554727, 3000554729, 3000554730, 3000556412, 3000556413, 3000556414, 3000556415;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA PIK 150Maquet Cardiopulmonary AG · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
Other devices under the same FDA submission
2 devices cleared under K131666 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NA PIK 100Maquet Cardiopulmonary AG · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA PIK dilator set largeMaquet Cardiopulmonary AG · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99668).
- Z-3144-2026 · Open, ClassifiedPercutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
- Z-3146-2026 · Open, ClassifiedPercutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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