—#45647

Product

CATH. GUIDE 6F SR3.5 LAUNCHER CATHETER LA6SR35 LA 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR35

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K021256
Affected lot / code info: Lot Numbers: 0000001696 0000005659 0000009476 0000042018 0000044719 0000045231 0000064050 0000068017 0000068397 0000082398 0000084406 0000085999 0000095233 0000104293 0000104342 0000115247 0000123723 0000125309 0000138086 0000150459 0000169173 0000176133 176535 186865 201667 204626 205350 211785 213371 214942 220436

Why it was recalled

Potential for non-sterility due to loss of package integrity

Root cause (FDA determination)

Other

Action the firm took

Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.

Recalling firm

Firm: Medtronic, Inc.
Address: 35 37A Cherry Hill Dr, Danvers, Massachusetts 01923-2565

Distribution

Distribution pattern: Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.

Timeline

Recall initiated: 2006-04-05
Posted by FDA: 2006-06-01
Terminated: 2007-06-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45647. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.