Edwards Lifesciences Research Medical, Inc. Recalls

All product recalls associated with Edwards Lifesciences Research Medical, Inc..

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Recall Summary

Total Recalls

10

Past Year

0

Class I (Serious)

0

Most Recent

Sep 2009

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–10 of 10 recalls

Edwards Lifesciences Research Medical, Inc.: EndoClamp aortic catheter. Label reading in part: "***CAR...

Balloon catheters were spontaneously rupturing during use.

FDASep 24, 2009Nationwide• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: EndoClamp aortic catheter label reading in part: "CARDIOV...

Spontaneous balloon rupture during use of the product.

FDASep 24, 2009Nationwide• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: Edwards Lifesciences CardioVations, EndoClamp aortic cath...

Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.

FDA

Nov 26, 2008

AL, AK, CA +32 more

• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: CardioVations Ethicon, a Johnson and Johnson company, End...

Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.

FDANov 26, 2008AL, AK, CA +32 more• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF ...

Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.

FDAJul 14, 2008AL, CA, LA +9 more• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cann...

Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury.

FDAFeb 25, 2008Nationwide• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm. ...

Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use.

FDAApr 18, 2006CA, CT, FL +7 more• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm...

Due to potential embrittlement of the plastic tip which may crack or separate during use.

FDAApr 18, 2006CA, CT, FL +7 more• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: Duraflo Treated Aortic Perfusion Cannula with plastic tip...

Due to potential embrittlement of the plastic tip which may crack or separate during use.

FDAApr 18, 2006CA, CT, FL +7 more• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical Inc: EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.

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

FDANov 19, 2004AL, CA, CO +21 more• Edwards Lifesciences Research Medical Inc

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Edwards Lifesciences Research Medical, Inc. Recalls

Recall Summary

Edwards Lifesciences Research Medical, Inc.: EndoClamp aortic catheter. Label reading in part: "***CAR...

Edwards Lifesciences Research Medical, Inc.: EndoClamp aortic catheter label reading in part: "CARDIOV...

Edwards Lifesciences Research Medical, Inc.: Edwards Lifesciences CardioVations, EndoClamp aortic cath...

Edwards Lifesciences Research Medical, Inc.: CardioVations Ethicon, a Johnson and Johnson company, End...

Edwards Lifesciences Research Medical, Inc.: Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF ...

Edwards Lifesciences Research Medical, Inc.: Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cann...

Edwards Lifesciences Research Medical, Inc.: Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm. ...

Edwards Lifesciences Research Medical, Inc.: Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm...

Edwards Lifesciences Research Medical, Inc.: Duraflo Treated Aortic Perfusion Cannula with plastic tip...

Edwards Lifesciences Research Medical Inc: EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.