Recalls / —

—#187656

Product

Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547

FDA product code

DXO — Transducer, Pressure, Catheter Tip

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K142749, K161962

Affected lot / code info

Lot # 63598812

Why it was recalled

There is a potential that the pressure tubing may detach from the blood sampling system

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On May 26, 2021 Edwards Lifesciences issued a "Urgent Medical Device Recall" Notification via FedEx to all affected consignees. In addition to informing consignees about the recalled product, the firm asked consignees to take the following actions: 1. Action to be taken by user: We request that you return all unused product in your inventory with the model and lot numbered reference above. For product that has been used and will be returned, please contact Customer Service at 1-800-424-3278 to request a biokit. Please review your inventory and quarantine any affected product until prepared for return to Edwards Lifesciences. Please follow the instructions included in the enclosed acknowledgement form an return within 5 days of receipt of this notification. 2. Action to be taken by distributor: Please complete the acknowledgement form and return to US.FCA@edwards.com. Please forward this customer communication to any of your customers who have purchased the impacted Edwards VAMP Jr. and TruWave/VAMP Jr. Products and ask them to return the product toe Edwards with the enclosed acknowledgement form. 3. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product and Edwards will communicate directly with your customers to facilitate the recall and acknowledgement process. Please forward your customer list to US.FCA@edwards.com 4. Adverse Event Reporting in the US: - Please contact the FDA's MedWatch Adverse Event reporting program either online, by regular mail, or by fa: Complete and submit the report Online: WWW.fda.gov/medwatch/report.htm - Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 5. Transmission of the Product Recall: This notice need to be passed on to all individuals within your organization who need to be aware of th

Recalling firm

Firm

Edwards Lifesciences, LLC

Address

1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern

US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy

Timeline

Recall initiated

2021-05-26

Terminated

2023-12-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #187656. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.