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Acumen IQ recallZ-0409-2024 · Edwards Lifesciences, LLC · initiated Oct 4, 2023

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

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

FDA root cause category: Device Design

What the company is doing

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 [email protected], 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.

Recall details

Recall number
Z-0409-2024
Status
Open, Classified
Initiated by the company
Oct 4, 2023
Posted by the FDA
Nov 29, 2023
Recalling firm
Edwards Lifesciences, LLC
Quantity
33,327 units
Product code
DRS
FDA submissions
K152980
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

Product description

Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.

Code information (models, lots, serial numbers)

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

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

10 devices cleared under K152980 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93279).

Sources and updates

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