Diversatek Healthcare recalls Viper 3-Stage Wire Guided Balloon Dilators with incorrect part numbers that could lead to improper balloon sizing and inflation risks 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 a specific balloon dilator used in medical procedures because the inflation tag might have wrong part numbers and balloon sizes. This could cause incorrect inflation pressures during use, potentially leading to injury.
The inflation tag may have incorrect part numbers, leading to mismatched balloon sizes and inflation pressures. This could cause improper dilation during medical procedures, potentially causing injury to the patient.
Medical professionals using the Viper 3-Stage Wire Guided Balloon Dilator for procedures like angioplasty. Patients undergoing such procedures are at risk if the device is used incorrectly.
Check for the model number REF 1205-18 and lot number 005985 on the device's UDI/DI label. The product was sold with specific balloon sizes (15mm-16.5mm-18mm).
Look for the UDI/DI number 00816734021798 and lot number 005985 on the device.
The recall is for potential incorrect part numbers that could lead to improper sizing and inflation. If the device is used correctly with the right part numbers, it may not be dangerous.
Check for the model number REF 1205-18 and lot number 005985 on the device's UDI/DI label.
The recall does not specify a remedy, so contact Diversatek Healthcare for further instructions.
We’ve drafted a message you can send Diversatek Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1940-2026 — Diversatek Healthcare Diversatek Healthcare Hello, I own a Diversatek Healthcare that is covered by recall Z-1940-2026 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.
