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Nuwellis, Inc.

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit	320111	FDA UDI	Class II	Active
Dual Lumen Extended Length Catheter	114153	FDA UDI	Class II	Active
AquaFlexFlow UF 500	114157	FDA UDI	Class II	Active
AquaFlexFlow UF 500 Plus	114156	FDA UDI	Class II	Active
Dual Lumen Extended Length Catheter (15cm) and GALT Insertion Kit	320112	FDA UDI	Class II	Active
Aquadex SmartFlow Console	120100	FDA UDI	Class II	Active
Dual Lumen Extended Length Catheter (11cm)	320101	FDA UDI	Class II	Active
Dual Lumen Extended Length Catheter and GALT insertion kit	115463	FDA UDI	Class II	Active
Blood Circuit Set	UF 500	FDA UDI	Class II	Active
AquaFlexFlow UF 500 Plus - 24 Hr	210104	FDA UDI	Class II	Active
Blood Circuit Set	UF 500-HCT	FDA UDI	Class II	Active
Dual Lumen Extended Length Catheter (15cm)	320102	FDA UDI	Class II	Active
Aquadex FlexFlow	114158	FDA UDI	Class II	Active
Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)	K252226	FDA 510(k)	Class II	Active
Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)	K233515	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 11, 2024	Z-0831-2025	—	completed	The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.