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