CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
Percutaneous Insertion Kit (PIK), Guidewire recalled
Maquet Cardiopulmonary is recalling Percutaneous Insertion Kit (PIK), Guidewire, distributed nationwide in the US. The recall was initiated on 31 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3145-2026
- FDA event ID
- 99668
- Recalling firm
- Maquet Cardiopulmonary, Rastatt, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jul 2026
- FDA classified
- 11 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 31 Jul 2026 | Recall initiated by company | |
| 11 Sep 2026 | Classified by FDA | +42 days |
| 23 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The packaging may not consistently maintain sterile barrier integrity.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Where it was 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;
Questions about this recall
Why was it recalled?
The packaging may not consistently maintain sterile barrier integrity.
Which lots are affected?
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, 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;
Where was it sold?
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;
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99668This product is part of a recall event; the main page for the event is Percutaneous Insertion Kit (PIK), Guidewire recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Percutaneous Insertion Kit (PIK), Guidewire recalled | Maquet Cardiopulmonary | Sterility | Nationwide | |
| CLASS II | Percutaneous Insertion Kit (PIK), dilator set recalled | Maquet Cardiopulmonary | Sterility | Nationwide |
More recalls from Maquet Cardiopulmonary
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Percutaneous Insertion Kit (PIK), dilator set recalled | Maquet Cardiopulmonary | Sterility | Nationwide |
| Device | CLASS II | Percutaneous Insertion Kit (PIK), Guidewire recalled | Maquet Cardiopulmonary | Sterility | Nationwide |
| Device | CLASS II | Bubble Sensor for 3/8" x 3/32" tubing recalled by Maquet Cardiopulmonary | Maquet Cardiopulmonary | Device Malfunction | Nationwide |
| Device | CLASS II | Sprinter Cart/Sprinter Cart XL Infusion Pole recalled | Maquet Cardiopulmonary | Device Malfunction | Nationwide |
| Device | CLASS II | Cardiohelp System HKH 8820 Wall Holder recalled | Maquet Cardiopulmonary | Device Malfunction | IL, MO |
Other Heart & Vascular Devices recalls
All 6,208| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |
| Device | CLASS II | EWO_02513 (Catalog number 320122) For Investigational Use Only Nano recalled | embecta Medical II | Other | Nationwide |
| Device | CLASS II | EWO_02512 (Catalog number 320550) For Investigational Use Only Nano recalled | embecta Medical II | Other | Nationwide |
| Device | CLASS I | Power-Trialysis Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |
| Device | CLASS I | Impella Optical Controller, Automated Impella Controller recalled | Abiomed | Device Malfunction | Nationwide |