Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravas
Summary
The FDA issued a Class II for Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, by Edwards Lifesciences, LLC. Reason: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer..
Details
Source
Device Recall
External ID
Z-0409-2024
Action Date
2023-12-06
Status
Ongoing
Category
device
Product Description
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
Lot/Code Info: 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
Quantity Affected: 33,327 units
Reason for Recall
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-04
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Edwards Lifesciences, LLC has 59 FDA actions in our database, including 35 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Edwards Lifesciences, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Edwards Lifesciences, LLC have FDA actions?
Edwards Lifesciences, LLC has 59 FDA actions in our database, including 35 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0409-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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