Facility

Nuwellis, Inc.

1 recall(s) on record — most severe on record: Class I.

Key facts

1recalls · worst Class I

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007137787
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	12988 Valley View Rd Eden Prairie, MN, US 55344
Registration status	Active · expires 2026
Parent company	Nuwellis, Inc. (owner-operator 10026935)
Brand names	Aquadex SmartFlow; Aquadex FlexFlow; dELC

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (2)

Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Product code NQJ (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5540
Catheter, Hemodialysis, Non-Implanted
Product code MPB (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5540

Recalls & enforcement

Class ICompleted2024-12-11
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…

FDA inspections (2)

NAI2023-04-13
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-12-06
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Nuwellis, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Nuwellis, Inc. (FEI 3007137787) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007137787-nuwellis-inc/

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