Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0109-2008 · Posted 2007-10-31

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKRA
Date Initiated2007-09-10
Date Terminated2007-12-20
Product Quantity153

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.

Firm 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

Root Cause

Packaging process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000177RENEGADE HI-FLO MICROCATHETERBoston Scientific Corp · 2000-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑