Z-3144-2026Class II

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

Name: Z-3144-2026 Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS)
Creator: Maquet Cardiopulmonary Gmbh
Published: 2026-07-31
License: https://open.fda.gov/license/

Maquet Cardiopulmonary Gmbh / initiated 2026-07-31 / Open, Classified

FDA source

Recall record

Recall number: Z-3144-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-31
Posted: 2026-09-11
Recalling firm: Maquet Cardiopulmonary Gmbh
Product: Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: The packaging may not consistently maintain sterile barrier integrity.
FDA root cause: Packaging
Action: On July 31, 2026 URGENT MEDICAL DEVICE REMOVAL letters were sent to customers. Customer Actions: 1. Ensure all affected, unused product in your inventory has been properly quarantined. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 3. Contact Customer Service via email at [email protected] or 888-943-8872, option 2 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone) to return your unused, unexpired, affected product. Credit will be issued for returned product. 4. Complete and return the enclosed response form to Getinge by e-mailing a copy to [email protected].
Quantity in commerce: 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;
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3144-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3144-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11
Z-3145-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11
Z-3146-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11

Product code DWF

K131666Class IIArterial Hls Cannula 13 Fr Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG / cleared 2013-07-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-15. View this recall on fda.gov (opens on fda.gov)