—#101234

Product

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 product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K010579, K990707
Affected lot / code info: Lot # : 0005199588

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Medtronic Vascular
Address: 35-37A Cherry Hill Drive, Danvers, Massachusetts 01923-2565

Distribution

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

Timeline

Recall initiated: 2011-06-08
Terminated: 2012-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101234. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.