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

Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

FDA Recall Z-2754-2011 · Posted None

Recalling FirmMedtronic Vascular
Recall StatusTerminated
Product CodeDQY
Date Initiated2011-06-08
Date Terminated2012-04-17
Product Quantity5 units

Reason for Recall

Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve

Firm Action

The firm, Medtronic, sent an "Urgent Medical Device Recall Notice(for US)" letter dated June 7, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to segregate the product so that it will not be used. A Medtronic Sales Representative will visit the customers to account for all units they received and initiate a credit as appropriate. If you have any questions, please call (978) 739-0371 or (978) 739-3259.

Root Cause

Labeling Change Control

Distribution Pattern

Nationwide distribution: USA including states of: CA, FL, and MA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010579STENT SUPPORT GUIDE CATHETERMedtronic Vascular · 2001-11-21K990707MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERSMedtronics Interventional Vascular · 1999-03-22

Official Source

View FDA Recall →

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

↑