—#46125

Product

6F ZUMA SR3.5 CATHETER ZM6SR35 ZM 6F 100CM SR3.5 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 Code: ZM6SR35

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K981198
Affected lot / code info: Lot Numbers: 0000005115 0000012614 0000014791 0000021492 0000049651 0000052460 0000102704 0000203280 129920 136399 138569

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 #46125. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.