Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.
FDA Recall Z-0578-2020 · Posted None
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2019-10-24
Date Terminated2023-03-20
Product Quantity14,145 devices total
Reason for Recall
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.
Firm Action
The firm, Boston Scientific, sent an "Urgent Medical Device Removal" letter dated 10/28/2019 overnight mail delivery to its customers. The letter stated the issue, identified affected product and stated that product should not be used. The customers were instructed, if any product is identified to segregate immediately and return to Boston Scientific. The customers were also instructed to Immediately complete the RECALL REMOVAL REPLY VERIFICATION TRACKING FORM and Scan/e-mail to: [email protected] OR Fax to #: 1-866-213-1806. This form must be completed and returned in all cases even if you do not have any affected product.
If you are a distributor, please note that the removal notification should be forwarded to your customers.
If you have any questions, contact Boston Scientific Quality Systems at
763-494-1133 or email: [email protected].
Root Cause
Process control
Distribution Pattern
Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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