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Terminated

EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.

FDA Recall Z-0306-05 · Posted 2004-12-15

Recalling FirmEdwards Lifesciences Research Medical Inc
Recall StatusTerminated
Product CodeDWF
Date Initiated2004-11-19
Date Terminated2005-01-07
Product Quantity396 units

Reason for Recall

Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.

Firm Action

All consignees were notified by letter on 11/22/2004

Root Cause

Other

Distribution Pattern

AL, CA, CO, FL, GA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OR, PA, RI, TN, TX, VA, WA, and WI. No foreign, military or government distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020693AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101Embol-X, Inc. · 2002-09-05

Official Source

View FDA Recall →

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

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