Edwards Lifesciences LLC

2023

• 4 Oct 2023 Z-0412-2024 Class II Ongoing Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.via FDA establishment Edwards Lifesciences Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA…
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  US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam
  Submission number: K152980
• 4 Oct 2023 Z-0413-2024 Class II Ongoing Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.via FDA establishment Edwards Lifesciences Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA…
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  US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam
  Submission numbers: K142749, K183413, K171996
• 4 Oct 2023 Z-0414-2024 Class II Ongoing Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.via FDA establishment Edwards Lifesciences Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA…
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  US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam
  Submission numbers: K142749, K181684, K183413, K896819
• 7 Sep 2023 Z-0238-2024 Class II Ongoing Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).via FDA establishment Edwards Lifesciences Distribution: OUS: Singapore, Taiwan, Canada Submission number: K892410
• 27 Jul 2023 Z-2479-2023 Class II Ongoing Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.via FDA establishment Edwards Lifesciences Distribution: International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece,…
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  International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland.
  Submission number: P220003
• 14 Feb 2023 Z-1379-2023 Class II Ongoing There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.via FDA establishment Edwards Lifesciences Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA…
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  US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None
• 14 Feb 2023 Z-1380-2023 Class II Ongoing There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.via FDA establishment Edwards Lifesciences Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA…
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  US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None

2022

• 6 Oct 2022 Z-0146-2023 Class II Ongoing Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.via FDA establishment Edwards Lifesciences Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,…
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  Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bulgaria, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guam, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Malta, Mauritius, Morocco, Netherlands, Nicaragua, Northern Ireland, Oman, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates (UAE), United Kingdom.
  Submission number: K193379
• 6 Oct 2022 Z-0147-2023 Class II Ongoing Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.via FDA establishment Edwards Lifesciences Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,…
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  Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bulgaria, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guam, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Malta, Mauritius, Morocco, Netherlands, Nicaragua, Northern Ireland, Oman, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates (UAE), United Kingdom.
  Submission number: K193379
• 1 Mar 2022 Z-0834-2022 Class II Ongoing The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatmentvia FDA establishment Edwards Lifesciences Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
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  Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, CANARY ISLANDS, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Northern Ireland, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), United Kingdom, Vietnam.
  Submission numbers: K143675, K203490
• 1 Mar 2022 Z-0835-2022 Class II Ongoing The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatmentvia FDA establishment Edwards Lifesciences Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
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  Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, CANARY ISLANDS, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Northern Ireland, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), United Kingdom, Vietnam.
  Submission numbers: K180003, K201446

2021

• 9 Jul 2021 Z-2278-2021 Class II Terminated There is a potential for internal leaks within catheters.via FDA establishment Edwards Lifesciences Distribution: US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland,…
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  US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada
  Submission number: K053609
• 9 Jul 2021 Z-2279-2021 Class II Terminated There is a potential for internal leaks within catheters.via FDA establishment Edwards Lifesciences Distribution: US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland,…
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  US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada
  Submission number: K053609
• 9 Jul 2021 Z-2280-2021 Class II Terminated There is a potential for internal leaks within catheters.via FDA establishment Edwards Lifesciences Distribution: US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland,…
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  US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada
  Submission number: K053609
• 9 Jul 2021 Z-2281-2021 Class II Terminated There is a potential for internal leaks within catheters.via FDA establishment Edwards Lifesciences Distribution: US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland,…
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  US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada
  Submission number: K053609