Z-0122-2007

Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990

Name: Z-0122-2007 Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990
Creator: Boston Scientific Corporation
Published: 2005-08-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-08-10 / Terminated

FDA source

Boston Scientific Corporation began a recall of Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990 on 2005-08-10. The reason FDA records is "Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0122-2007
Status: Terminated
Initiated: 2005-08-10
Posted: 2006-11-01
Terminated: 2012-05-16
Recalling firm: Boston Scientific Corporation
Product: Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990
Product code: KRA Catheter, Continuous Flush
Reason for recall: Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04
FDA root cause: Other
Action: Recall notification packages including a Reply Verification Tracking Form were sent to Boston Scientific representatives via Fed Ex on 8/10/2005. Boston Scientific representatives delivered the packages to the consignees. The Consignees were instructed to return affected product to Boston Scientific to be relabeled.
Quantity in commerce: 5 units
Distribution: TX, KY
Product codes and lots: Lot Number: 7552069

Product code KRA

K000177Class IIRenegade Hi-Flo MicrocatheterBoston Scientific Corp / cleared 2000-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)