Dialysis Blood Circuit May Cause Excessive Fluid Removal
The AquaFlexFlow UF 500 Plus blood circuit may malfunction and remove excessive fluid from patients, causing a dangerous drop in blood volume. This risk is especially dangerous for pediatric patients.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall involving potential for serious patient harm through Acute Volume Depletion and dangerously low blood pressure. No illnesses or injuries have been reported, but the hazard represents a confirmed device malfunction risk in a critical patient care application, particularly dangerous for pediatric patients.
Plain-English summary
The AquaFlexFlow UF 500 Plus is an extracorporeal blood circuit component used with Aquadex SmartFlow and FlexFlow systems. These systems are used in medical settings to remove excess fluid from patients during dialysis or ultrafiltration procedures.
Nuwellis Inc. is recalling 845 units of this blood circuit due to a malfunction where the circuit may display "Ultrafiltrate Weight Mismatch" or excessive weight mismatch alarms while in use. When this malfunction occurs, the system may remove excessive amounts of fluid from the patient, leading to Acute Volume Depletion—a dangerous drop in blood volume that can cause dangerously low blood pressure and other serious complications. This risk is especially dangerous for pediatric patients.
The affected product was distributed nationwide in the United States and to Hong Kong. The specific lot numbers involved are: 22697, 22698, 22699, 22700, 22701, 22702, 22703, 22704, 22705, 22706, 22707, 22708, 22721, 22722, 22723, 22724, 22733, 22734, 22735, 22736, 22737, 22738, 22739, and 22740.
Healthcare facilities using affected units should contact Nuwellis Inc. immediately for further guidance and instructions on safe handling of this product.
The recalled product
- Product
- nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
- Manufacturer
- Nuwellis Inc
- Affected units
- 845
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: 22697
- 22698
- 22699
- 22700
- 22701
- 22702
- 22703
- 22704
- 22705
- 22706
- 22707
- 22708
- 22721
- 22722
- 22723
- 22724
- 22733
- 22734
- 22735
- 22736
Distribution
Distributed nationwide across the United States.
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