Percutaneous Insertion Kit recall: Sterility Concern

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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;

Product

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

Recalling firm

Maquet Cardiopulmonary Gmbh

Quantity

68371 units (1765 US, 66606 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, United Kingdom;

Recall date

September 23, 2026

Classification

Class II

Status

Ongoing

Agency

FDA (device)