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Terminated

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

FDA Recall Z-0208-2007 · Posted 2006-11-22

Recalling FirmMedtronic Vascular
Recall StatusTerminated
Product CodeITX
Date Initiated2006-11-01
Date Terminated2007-12-05
Product Quantity502

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Switzerland, France, Belgium, Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031920CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001Trans Vascular Incorporated · 2003-07-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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