Diversatek Healthcare recalls Viper 3-Stage Fixed Wire Balloon Dilators (6-8mm) with incorrect inflation tags that could lead to improper balloon sizing and pressure issues during medical procedures.
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.
Diversatek Healthcare is recalling its Viper 3-Stage Fixed Wire Balloon Dilators (6mm-7mm-8mm) because the inflation tag might have wrong part numbers and balloon sizes. This could cause improper dilation during medical procedures if used incorrectly.
The inflation tag on the device may list incorrect balloon diameter sizes and inflation pressures for each stage. This could lead to improper dilation during medical procedures if the device is used with the wrong settings.
Healthcare professionals using the Viper 3-Stage Fixed Wire Balloon Dilators for medical procedures are likely affected. Patients receiving these devices during procedures may be at risk if the incorrect sizing causes complications.
Check for the product name 'Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm' with reference number REF 1204-08. The lot number is 005983, and the UDI/DI code is 00816734021699.
Verify the reference number (REF 1204-08) and lot number (005983) on the device's packaging or label.
The recall does not state that the device is dangerous when used correctly; it only indicates potential issues with the inflation tag.
The recall record does not specify a remedy, so no action is required based on the information provided.
Look for the product name 'Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm' with reference number REF 1204-08 and lot number 005983.
We’ve drafted a message you can send Diversatek Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1938-2026 — Diversatek Healthcare Diversatek Healthcare Hello, I own a Diversatek Healthcare that is covered by recall Z-1938-2026 from Diversatek Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
