—#45673

Product

CATH. GUIDE 7F SR4.0 LAUNCHER CATHETER LA7SR40 LA 7F 100CM SR40 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: LA7SR40

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022764
Affected lot / code info: Lot Numbers: 0000009532 0000013672 0000019809 0000022777 0000044800 0000045282 0000050729 0000056338 0000075247 0000076693 0000083944 0000096010 0000107906 0000123126 0000132923 175760 178292 180185 181735 182416 182417 183000 188007 203620 206606 212408 213693 219667

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 #45673. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.