VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a… recallZ-0759-04 · Boston Scientific Corporation · initiated Mar 5, 2004
Terminated All recalls posted in July 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.
FDA root cause category: Other
What the company is doing
Letter dated 3/5/04 with instructions to return product.
Recall details
- Recall number
- Z-0759-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 5, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 75 units (box/10)
- Product code
- DRE
- FDA submissions
- K974640
- Distribution
- 42 domestic hospitals nationwide and one distributor in Canada.
Product description
VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-988. Firm on the label: Boston Scientific.
Code information (models, lots, serial numbers)
912502, Exp. 10/31/05
Other devices under the same FDA submission
1 device cleared under K974640 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vaxcel 45984Navilyst Medical, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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