—#46126

Product

6F ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 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: ZM6SR40

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K981198
Affected lot / code info: Lot Numbers: 0000000770 0000002134 0000028207 0000043814 0000090410 0000103759 0000125699 0000137834 0000151268 0000164481 127482 128283 128616 128988 130040 130595 132042 134208 135297 136396 138223 139414 141461 145170 152777 154356 155657 160606 166965 175986 186044 188373 204387 208088 217819 223496

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 #46126. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.