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Terminated

LigaSure Atlas Laparoscopic Vessel Sealer/Divider

FDA Recall Z-0772-06 · Posted 2006-04-19

Recalling FirmCovidien LP
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-01-27
Date Terminated2008-08-15
Product Quantity124,000 units domestic, 126,000 units internationally.

Reason for Recall

Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.

Firm Action

Consignees were notified by letter on 01/27/2006.

Root Cause

Other

Distribution Pattern

Nationwide, including 52 VA facilities and 12 military facilities. Foreign distribution to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatamala, Israel, Japan, Mexico, Paraguay, Peru, Singapore, South Africa, Uruguay, Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010013LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100Valleylab, Inc. · 2001-03-26

Official Source

View FDA Recall →

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

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