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Terminated

Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY. The Snare Kit contains a pouch labeled a "Snare Catheter" and a pouch labeled "Amplatz Goose Neck Snare". Snare Catheter

FDA Recall Z-0992-2007 · Posted 2007-07-11

Recalling FirmEv3, Inc
Recall StatusTerminated
Product CodeDXE
Date Initiated2007-05-18
Date Terminated2008-10-17
Product Quantity23 units

Reason for Recall

Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr.

Firm Action

Letter May 18, 2007.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Belgium, France, Germany, Italy, Jordan, Spain, United Kingdom, and Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972511AMPLATZ GOOSE NECK SNARE KIT/ CATHETERMicrovena Corp. · 1998-03-06

Official Source

View FDA Recall →

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

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