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, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.

FDA Recall Z-1164-2014 · Posted 2014-03-10

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2014-03-03
Date Terminated2014-06-09
Product Quantity7

Reason for Recall

The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.

Firm Action

Consignees were sent a Boston Scientific "Urgent Medical Device Recall Removal " letter dated March 3, 2014. The letter described the problem and the product involved in the recall. The letter advised consignees to return the affected product and to complete and return the Account Reply Verification Tracking Form. The local Sales Representative can answer any questions that you may have regarding this Recall Removal.

Root Cause

Packaging

Distribution Pattern

TX and Russia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033441BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETERBoston Scientific Corp · 2003-11-21

Official Source

View FDA Recall →

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

↑