Date Initiated by Firm |
October 04, 2023 |
Date Posted |
November 29, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0409-2024 |
Recall Event ID |
93279 |
510(K)Number |
K152980
|
Product Classification |
Transducer, blood-pressure, extravascular - Product Code DRS
|
Product |
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring. |
Code Information |
AIQS6: UDI:00690103201079; Lot #s: 64858340 64933520 65027617;
AIQS65: UDI:00690103200935; Lot # 64858715;
AIQS6R: UDI:00690103201093/Lot #: 64858050
AIQS6R5: UDI:00690103200959/Lot #: 64835570
AIQS8: 00690103201086 UDI:/Lot # 64858150 64858716 64891667 64939370 65179001;
AIQS85: UDI:00690103200942/Lot# 64858717 64892324 64892325 64892326 64892327 64904497 64904498 64918260 64918261 64918262 64918263 64918264 64918646 64918647 64918648 64918649 64918650 64918651 64918652 64988038 64988040 65067612;
AIQS8R5: 00690103201178/UDI:; Lot # 64817843 64858645 64891410
|
Recalling Firm/ Manufacturer |
Edwards Lifesciences, LLC 1 Edwards Way Irvine CA 92614-5688
|
For Additional Information Contact |
Linnette Torres 949-250-6827
|
Manufacturer Reason for Recall |
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
|
FDA Determined Cause 2 |
Device Design |
Action |
On 10/18/2023, Edwards Lifesciences issued a "Urgent: Medical device Correction Action via FedEx mail. Edwards ask consignees to take the following actions:
1. Follow the IFU for proper setup and flushing of your device.
2. Follow the instructions included in the enclosed customer acknowledgement form to complete the acknowledgement process.
3. Verify your inventory on the attached customer acknowledgement form.
3a.E-mail the completed form to Edwards Customer Service at US.FCA@edwards.com, within 15 days from receipt of this notification.
4. Distribute this notice within your organization or to any organization where the potentially impacted product has been transferred.
5. Please post a copy of this notice near and/or with affected devices.
6. Contact Edwards Customer Service at 1-888-352-0904 if you would like to return any of your devices or have further questions.
7. Action Requested for Distributors:
In addition to the actions above, please forward this customer communication to any of your customers who have purchased the impacted product.
|
Quantity in Commerce |
33,327 units |
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 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
|
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = DRS and Original Applicant = Edwards Lifesciences, LLC
|