Acumen IQ Sensor Intravascular Pressure Monitor Flushing Difficulty
Edwards Lifesciences is recalling 33,327 Acumen IQ Sensors used for intravascular pressure monitoring due to potential flushing difficulties during setup. The devices are distributed across the US and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The device is FDA Class II with no reported deaths, injuries, or hospitalizations. The hazard involves potential flushing difficulties during setup of the pressure monitoring system. This represents a risk-of-harm scenario for a critical-care device, but without confirmed injuries, aligning with High severity criteria.
Plain-English summary
Edwards Lifesciences is recalling 33,327 Acumen IQ Sensor units used for intravascular pressure monitoring. The recalled device references are AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, and AIQS8R5. These are sterile devices intended for use in intravascular pressure monitoring.
The FDA Class II recall was issued due to potential for flushing difficulties during the setup of the pressure monitoring kit with the pressure transducer.
The affected devices have been distributed throughout the United States and to over 40 international locations worldwide. Specific lot numbers have been identified for each device reference number.
The recalled product
- Product
- Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 33,327
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- AIQS6: UDI:00690103201079
- Lot #s: 64858340 64933520 65027617
- AIQS65: UDI:00690103200935
- Lot # 64858715
- AIQS8R5: 00690103201178/UDI:
- Lot # 64817843 64858645 64891410
Distribution
Part of a larger recall action
This product is one of 6 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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