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 mismatched balloon diameter sizes and inflation pressures. This could cause improper dilation during medical procedures, potentially leading to injury.
Medical professionals using the specific model numbers listed in the recall. Patients undergoing procedures with these devices are at risk if the incorrect part numbers lead to improper sizing.
Check for the model name 'Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm' and the reference number REF 1205-20. The lot numbers 004947, 004950, 005311, 005397, 005484, and 005574 are affected.
Look for the inflation tag on the device to verify the part number matches the correct specifications.
The Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm with reference number REF 1205-20 and lot numbers 004947, 004950, 005311, 005397, 005484, and 005574.
The inflation tag may contain an incorrect part number, which could lead to mismatched balloon sizes and inflation pressures during medical procedures.
Check the inflation tag for the correct part number. If it's incorrect, contact Diversatek Healthcare 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-1941-2026 — Diversatek Healthcare Diversatek Healthcare Hello, I own a Diversatek Healthcare that is covered by recall Z-1941-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
