Warning
Diversatek Healthcare Recalls Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1938-2026Medical Device
Diversatek Healthcare Recalls Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon
Diversatek Healthcare · Class II — Moderate Risk
Product Description
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Reason for Recall
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. Diversatek Healthcare initiated the recall on March 18, 2026 affecting 15 units. The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Diversatek Healthcare for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects.