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Terminated

Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029

FDA Recall Z-0523-04 · Posted 2004-02-10

Recalling FirmMedtronic, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2004-01-14
Date Terminated2004-11-15
Product Quantity20 units

Reason for Recall

Catheter distal tip may separate

Firm Action

Medtronic notified sales representatives/distributors on 1/14/04 via telephone and email and requested to retrieve affected product from the hospitals and return it to Danvers, MA. A script and effectiveness document was provided and to be reviewed with the hospital.

Root Cause

Other

Distribution Pattern

NC, WA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932092USCI ANGIOGRAPHIC CATHETERC.R. Bard, Inc. · 1993-07-29

Official Source

View FDA Recall →

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

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