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FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10 recallZ-0835-2022 · Edwards Lifesciences, LLC · initiated Mar 1, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software in the Use Environment

What the company is doing

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.

Recall details

Recall number
Z-0835-2022
Status
Open, Classified
Initiated by the company
Mar 1, 2022
Recalling firm
Edwards Lifesciences, LLC
Quantity
8389 units
Product code
MUD
FDA submissions
K180003, K201446
Distribution
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.

Product description

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

Code information (models, lots, serial numbers)

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10, UDI: 00690103208573; All serial numbers.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 89647).

Sources and updates

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