Z-0109-2008

Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303

Name: Z-0109-2008 Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303
Creator: Boston Scientific Corporation
Published: 2007-09-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-09-10 / Terminated / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303 on 2007-09-10. The reason FDA records is "Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0109-2008
Status: Terminated
Initiated: 2007-09-10
Posted: 2007-10-31
Terminated: 2007-12-20
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303
Product code: KRA Catheter, Continuous Flush
Reason for recall: Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Boston Scientific issued a Urgent Medical Device Recall Letter dated September 10, 2007 to Domestic accounts via Federal Express. The notification instructed the account to immediately discontinue the use of the product under this recall, check their inventory, remove any affected product , and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form
Quantity in commerce: 153
Distribution: Nationwide
Product codes and lots: Lot Numbers: 9218692; 9218628; 9218451

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)