Reported Dec 4, 2019 · Terminated
Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide
- Packaged in the following sizes
1. REF/Catalog No. H74939335150606F2. REF/Catalog No H74939335150707F
- Lot codes and dates
- Lot / GTIN Number / Use By
1. 23485544 / 8714729939450 / 2021-02-1023933296 / 8714729939450 /2021-05-1023947883 / 8714729939450 / 2021-05-1224137846 / 8714729939450 / 2021-06-17. 2
- Lots
21305995 / 8714729939474 / 2019-09-2524201181 / 8714729939474 / 2021-06-30
- Lot / GTIN Number / Use By
- Amount recalled
- 14,145 devices total
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
Why it was recalled
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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