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 specific models of their Viper 3-Stage Wire Guided Balloon Dilators due to potential incorrect part numbers on the inflation tags. This could result in improper balloon sizing and inflation pressures during medical procedures, which may cause injury.
The inflation tag on the device may have an incorrect part number, which can lead to wrong balloon diameter sizes and inflation pressures for each stage. This could cause improper sizing during medical procedures, potentially leading to injury.
Medical professionals using the recalled Viper 3-Stage Wire Guided Balloon Dilators for procedures. Patients receiving these devices during medical treatments are at risk if the incorrect part numbers lead to improper sizing.
Check for the product name 'Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm' with reference number REF 1205-15. Look for UDI/DI code 00816734021781 and lot numbers 004758, 005124, 005309, or 005629.
Verify the product's UDI/DI code and lot numbers to confirm if it is part of the recall.
The catheter inflation tag may contain an incorrect part number with wrong balloon diameter sizes and inflation pressures for each stage, which could lead to improper sizing during medical procedures.
Check for the product name 'Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm' with reference number REF 1205-15, UDI/DI code 00816734021781, and lot numbers 004758, 005124, 005309, or 005629.
The recall record does not specify a remedy, so contact Diversatek Healthcare directly for guidance.
We’ve drafted a message you can send Diversatek Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1939-2026 — Diversatek Healthcare Diversatek Healthcare Hello, I own a Diversatek Healthcare that is covered by recall Z-1939-2026 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.
