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TemporaryFDAOngoing

Can cause harm that is usually temporary.

Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);

Check the device or its packaging for

Model Number (USA): 701053068; UDI-DI: 4037691519883; Lot Numbers: 3000324477, 3000333824, 3000336037, 3000341450, 3000343893, 3000377475, 3000387891, 3000403656, 3000414516, 3000430803, 3000441821, 3000453326, 3000471523, 3000476321, 3000485151, 3000496204, 3000510428, 3000518006, 3000554731; Model Number (OUS): 701047384; UDI-DI: 4037691730660; Lot Numbers: 3000324479, 3000324480, 3000328829, 3000328830, 3000328831, 3000331203, 3000331204, 3000331206, 3000331224, 3000333819, 3000333820, 3000334780, 3000334781, 3000334782, 3000336034, 3000336035, 3000338097, 3000338098, 3000339838, 3000339839, 3000341457, 3000341458, 3000342412, 3000342413, 3000343902, 3000343903, 3000347872, 3000347873, 3000349433, 3000350472, 3000350473, 3000350474, 3000351949, 3000351950, 3000353375, 3000354955, 3000354956, 3000354957, 3000356333, 3000356334, 3000356335, 3000357761, 3000357762, 3000359475, 3000364061, 3000364062, 3000369310, 3000369312, 3000369316, 3000372382, 3000372383, 3000373778, 3000373779, 3000374100, 3000375677, 3000375678, 3000375679, 3000378518, 3000378519, 3000379856, 3000382445, 3000384006, 3000385167, 3000385168, 3000387892, 3000387893, 3000390768, 3000392520, 3000393467, 3000393468, 3000397030, 3000398789, 3000400250, 3000404891, 3000404892, 3000408177, 3000408178, 3000408179, 3000410260, 3000413601, 3000413602, 3000414518, 3000414519, 3000417088, 3000418477, 3000418478, 3000420374, 3000420375, 3000423667, 3000423674, 3000425774, 3000431820, 3000431821, 3000434595, 3000434596, 3000434597, 3000434598, 3000438009, 3000438010, 3000441823, 3000444273, 3000444274, 3000445644, 3000445976, 3000445977, 3000448171, 3000448172, 3000449726, 3000451983, 3000453329, 3000453330, 3000455122, 3000455123, 3000461218, 3000461219, 3000466034, 3000466035, 3000468419, 3000468420, 3000468421, 3000471524, 3000471525, 3000471526, 3000471527, 3000475598, 3000477178, 3000477182, 3000478745, 3000478834, 3000479561, 3000479563, 3000481002, 3000481003, 3000481944, 3000485139, 3000485141, 3000486782, 3000486787, 3000488306, 3000488307, 3000489894, 3000491429, 3000493064, 3000496195, 3000498672, 3000501301, 3000501302, 3000502838, 3000502839, 3000503938, 3000504934, 3000504935, 3000506575, 3000506576, 3000507640, 3000507642, 3000508153, 3000522416, 3000522469, 3000523507, 3000523508, 3000525035, 3000525036, 3000525037, 3000525038, 3000525457, 3000525458, 3000525459, 3000526917, 3000526918, 3000528230, 3000528713, 3000530040, 3000533974, 3000534003, 3000535434, 3000537044, 3000539529, 3000539530, 3000539531, 3000543967, 3000547000, 3000549187, 3000549188, 3000550935, 3000553328, 3000553329, 3000554725, 3000554726;
Why
The packaging may not consistently maintain sterile barrier integrity.
Distributed
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;
Company
Maquet Cardiopulmonary Gmbh
Announced
This is the date the recall was announced. A company may have started it weeks earlier.
Recall began

Source: FDA record Z-3144-2026 · retrieved 11 September 2026

Read the official notice

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