Reported Sep 23, 2026 · Ongoing
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Maquet Cardiopulmonary GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiopulmonary Gmbh · Kehler Str. 31 · Rastatt
Is this the product you have?
- Percutaneous Insertion Kit (PIK), Guidewire 150 cm
- Model Numbers
701053069 (USA)701047385 (OUS)
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 Model Number (USA): 701053069 2 4037691730677UDI-DI: 4037691730677 3 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 4 Model Number (OUS): 701047385 5 4037691519876UDI-DI: 4037691519876 6 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, 3000342421, 3000342422, 3000343894, 3000343895, 3000343896, 3000343897, 3000343898, 3000343899, 3000343900, 3000343901, 3000345720, 3000345721, 3000345722, 3000345723, 3000345724, 3000345725, 3000345726, 3000345727, 3000345728, 3000345729, 3000347867, 3000347868, 3000347869, 3000347870, 3000349429, 3000349430, 3000349431, 3000349432, 3000349434, 3000350476, 3000350477, 3000350478, 3000350479, 3000351515, 3000351516, 3000351517, 3000351518, 3000351951, 3000351952, 3000351953, 3000351954, 3000353376, 3000353377, 3000353378, 3000353379, 3000353380, 3000354958, 3000354959, 3000354960, 3000356336, 3000356337, 3000356338, 3000356339, 3000357758, 3000357759, 3000357760, 3000359472, 3000359473, 3000359474, 3000359476, 3000363549, 3000363550, 3000369079, 3000369080, 3000369265, 3000369266, 3000369317, 3000369318, 3000369320, 3000370467, 3000370468, 3000370469, 3000370470, 3000372386, 3000372387, 3000372388, 3000372389, 3000373780, 3000373781, 3000373782, 3000373783, 3000374102, 3000374103, 3000375675, 3000375676, 3000377476, 3000377477, 3000377478, 3000378520, 3000378521, 3000378522, 3000378523, 3000379857, 3000379858, 3000379859, 3000382446, 3000382447, 3000382448, 3000382449, 3000384008, 3000384009, 3000384012, 3000384013, 3000384018, 3000385169, 3000385171, 3000385172, 3000385173, 3000387896, 3000387897, 3000387898, 3000387899, 3000389001, 3000389002, 3000389003, 3000389004, 3000389005, 3000390764, 3000390765, 3000390766, 3000390767, 3000392517, 3000392518, 3000392519, 3000392521, 3000392523, 3000393469, 3000393471, 3000393472, 3000395577, 3000395578, 3000395579, 3000395580, 3000397025, 3000397027, 3000397028, 3000397029, 3000397033, 3000397034, 3000398275, 3000398786, 3000398787, 3000398788, 3000400244, 3000400245, 3000400246, 3000400247, 3000400248, 3000400249, 3000404886, 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 - Amount recalled
- 185617 units (5926 US, 179691 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The packaging may not consistently maintain sterile barrier integrity.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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