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Edwards Lifesciences Research Medical

Country not established

Devices
6
FDA recalls
17

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Edwards Lifesciences Research Medical makes

The company manufactures cannulae for cardiopulmonary bypass and perfusion, including retrograde cardioplegia cannulas, venous return cannulae, and arterial perfusion cannulae. It also produces modifications to intra-aortic embolic protection filters with heparin-coated mesh. Additional products include a T-anastomosis device for vascular connections.

These devices are classified as Class II under FDA regulations and are recorded in the 510(k) premarket notification database. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue6

Newest first, rows 1-6 of 6

FDA recalls17

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 17 recalls initiated by Edwards Lifesciences Research Medical, the earliest on 2004-11-19 and the most recent on 2009-09-24. By recorded status: 17 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 17 recalls.

  • 2009

    • 24 Sep 2009 Z-0084-2010 Unclassified (pre-2012) Terminated Balloon catheters were spontaneously rupturing during use. Distribution: Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand. Submission numbers: K955132, K962510, K964161
    • 24 Sep 2009 Z-0085-2010 Unclassified (pre-2012) Terminated Spontaneous balloon rupture during use of the product. Distribution: Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand. Submission numbers: K955132, K962510, K964161, K974175

  • 2008

    • 26 Nov 2008 Z-0644-2009 Unclassified (pre-2012) Terminated Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173. Distribution: Globally - USA including the states of AK, AL, CA, CO, CT, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS,…
      Full distribution text Globally - USA including the states of AK, AL, CA, CO, CT, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. VA facilities in VA and WI. No military distribution. Foreign distribution to Australia, Canada, Switzerland and UK.
      Submission number: K964161
    • 26 Nov 2008 Z-0645-2009 Unclassified (pre-2012) Terminated Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173. Distribution: Globally - USA including the states of AK, AL, CA, CO, CT, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS,…
      Full distribution text Globally - USA including the states of AK, AL, CA, CO, CT, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. VA facilities in VA and WI. No military distribution. Foreign distribution to Australia, Canada, Switzerland and UK.
      Submission number: K964161
    • 14 Jul 2008 Z-2401-2008 Unclassified (pre-2012) Terminated Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow. Distribution: Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of…
      Full distribution text Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.
      Submission number: K831769
    • 14 Jul 2008 Z-2402-2008 Unclassified (pre-2012) Terminated Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow. Distribution: Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of…
      Full distribution text Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.
      Submission number: K831769
    • 14 Jul 2008 Z-2403-2008 Unclassified (pre-2012) Terminated Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow. Distribution: Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of…
      Full distribution text Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.
      Submission number: K831769
    • 25 Feb 2008 Z-1893-2008 Unclassified (pre-2012) Terminated 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. Distribution: Nationwide Distribution. Submission numbers: K033464, K891576
    • 25 Feb 2008 Z-1894-2008 Unclassified (pre-2012) Terminated 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. Distribution: Nationwide Distribution. Submission numbers: K033464, K891576

  • 2006

    • 18 Apr 2006 Z-1089-06 Unclassified (pre-2012) Terminated Due to potential embrittlement of the plastic tip which may crack or separate during use. Distribution: CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU,…
      Full distribution text CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
      Submission number: K831769
Show all 17 recalls

  • 2006

    • 18 Apr 2006 Z-1090-06 Unclassified (pre-2012) Terminated Due to potential embrittlement of the plastic tip which may crack or separate during use. Distribution: CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU,…
      Full distribution text CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
      Submission number: K831769
    • 18 Apr 2006 Z-1091-06 Unclassified (pre-2012) Terminated Due to potential embrittlement of the plastic tip which may crack or separate during use. Distribution: CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU,…
      Full distribution text CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
      Submission number: K831769
    • 18 Apr 2006 Z-1092-06 Unclassified (pre-2012) Terminated Due to potential embrittlement of the plastic tip which may crack or separate during use. Distribution: CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU,…
      Full distribution text CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
      Submission number: K831769
    • 18 Apr 2006 Z-1093-06 Unclassified (pre-2012) Terminated Due to potential embrittlement of the plastic tip which may crack or separate during use. Distribution: CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU,…
      Full distribution text CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
      Submission number: K831769
    • 18 Apr 2006 Z-1094-06 Unclassified (pre-2012) Terminated Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use. Distribution: CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU,…
      Full distribution text CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
    • 18 Apr 2006 Z-1095-06 Unclassified (pre-2012) Terminated Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use. Distribution: CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU,…
      Full distribution text CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan

  • 2004

    • 19 Nov 2004 Z-0306-05 Unclassified (pre-2012) Terminated Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery. Distribution: 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…
      Full distribution text 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.
      Submission number: K020693

Frequently asked questions

How many devices does Edwards Lifesciences Research Medical have in the registry?

The registry currently lists 6 devices for Edwards Lifesciences Research Medical. Devices recorded under merged duplicate company entries are counted once.

Which registries list Edwards Lifesciences Research Medical's devices?

Among its 6 most recently registered devices, Edwards Lifesciences Research Medical has devices listed in FDA 510(k) (6 devices).

What risk classes do Edwards Lifesciences Research Medical's devices fall under?

Among its 6 most recently registered devices, the classes recorded for Edwards Lifesciences Research Medical's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Edwards Lifesciences Research Medical?

FDA recall records list 17 recalls initiated by Edwards Lifesciences Research Medical, the most recent initiated on 24 Sep 2009. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Edwards Lifesciences Research Medical in the registry?

The most recently registered devices listed for Edwards Lifesciences Research Medical include RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014, VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE, MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH and T-ANASTAFLO.

Generated automatically from registry data and not verified by a human reviewer.