Reported Dec 6, 2023 · Ongoing
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Acumen IQ Sensor
- REFsAIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring
- Lot codes and dates
8 of 8 products
Products covered by this recall # Barcodes Product as published 1 00690103201079UDI:00690103201079 2 Lot #s: 64858340 64933520 65027617 3 00690103200935AIQS65: UDI:00690103200935 4 Lot # 64858715 5 006901032010930069010320095900690103201086AIQS6R: UDI:00690103201093/Lot #: 64858050 AIQS6R5: UDI:00690103200959/Lot #: 64835570 AIQS8: 00690103201086 UDI:/Lot # 64858150 64858716 64891667 64939370 65179001 6 00690103200942AIQS85: 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 7 00690103201178AIQS8R5: 00690103201178/UDI 8 Lot # 64817843 64858645 64891410 - Amount recalled
- 33,327 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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