Acutus Medical AcQGuide Introducer Recalled for Foreign Material Particulates
Acutus Medical Inc is recalling 268 units of AcQGuide Mini Fixed-Curve Introducers because manufacturing defects may have left foreign material on the devices.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly states that the hazard could result in pulmonary embolism, which is a significant injury report.
Plain-English summary
Acutus Medical Inc is recalling 268 units of the AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle. The recall involves specific lots with expiration dates in October and December 2020. The affected devices were distributed in California, South Carolina, and Arizona.
The recall was initiated because the manufacturing process may have left foreign material particulates on the finished device. The presence of these particulates could result in a range of adverse events, from procedure delay to pulmonary embolism.
Healthcare providers and patients should stop using the affected devices and contact Acutus Medical Inc for further instructions.
The recalled product
- Product
- Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
- Manufacturer
- Acutus Medical Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 268
Distribution
Part of a larger recall action
This product is one of 4 recalled by Acutus Medical Inc 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.
See all 4 products in this recall →Related recalls
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