Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.

FDA Recall Z-0834-2022 · Posted None

Recalling FirmEdwards Lifesciences, LLC
Recall StatusOpen, Classified
Product CodeMUD
Date Initiated2022-03-01
Product Quantity402 units

Reason for Recall

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 treatment

Firm Action

Urgent Medical Device Correction communication dated March 01, 2022 was sent via FedEx 2nd Day Advice on action to be taken by user: Customers are to refrain from using the large sensors on certain somatic locations (arms and legs). Cerebral and flank/abdomen locations for the large sensors are not impacted. Instructions for customers: " Review the customer letter for advice on how to use impacted product. " Please follow the instructions included in the enclosed acknowledgement form to complete the acknowledgement process. " Do not return any product. " Distribute this notice within your organization or to any organization where the potentially impacted product has been transferred. " Verify your inventory. " E-mail the completed form to Edwards Technical Support at [email protected], within 15 days from receipt of this notification. Advice on action to be taken by Distributor: Please review this letter and complete the acknowledgement form. Return the acknowledgement form to [email protected] within 15 days of receipt of this notification. Please forward this customer communication to any of your customers who have purchased the impacted Edwards product. If you still have product within your control, please do not distribute impacted product to any customers. You can call Edwards Tech Support for instructions for handling product still within your control. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product from you and Edwards will communicate directly with your customers to facilitate the correction and acknowledgement process. Please forward your customer list to [email protected]. If you have any questions, please contact Edwards Tech Support at 1 (800)-822-9837 If you have questions, contact Edwards Tech Support at 1 (800)-822-9837 from 5:00AM--4:30PM PST.

Root Cause

Software in the Use Environment

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC · 2021-02-10

Official Source

View FDA Recall →

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

↑