—#49447

Product

Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403

FDA product code: ITX — Transducer, Ultrasonic, Diagnostic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031920
Affected lot / code info: All Codes.

Why it was recalled

Sterility may be compromised as evidenced by a loss of package integrity.

Root cause (FDA determination)

Other

Action the firm took

On 11/1/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

Recalling firm

Firm: Medtronic Vascular
Address: 5345 Skylane Boulevard, Santa Rosa, California 95403-1044

Distribution

Distribution pattern: Worldwide, including USA, Switzerland, France, Belgium, Germany.

Timeline

Recall initiated: 2006-11-01
Posted by FDA: 2006-11-22
Terminated: 2007-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49447. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.