Acutus Medical Recalls AcQGuide Flex Steerable Introducer Due to Foreign Material
Acutus Medical Inc is recalling 5 units of the AcQGuide Flex Steerable Introducer because manufacturing defects may have left foreign material particulates on the device.
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 source text explicitly states that the defect could result in pulmonary embolism, which constitutes a significant injury report under the severity rubric.
Plain-English summary
Acutus Medical Inc is recalling 5 units of the AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly. The recall affects lot number 19101020 with an expiration date of October 2020. The product was 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 source text states that this defect could result in a range of events from procedure delay to pulmonary embolism.
Healthcare providers and facilities that have received these specific units should stop using them and contact Acutus Medical Inc for further instructions. Consumers should not use the device if they have it in their possession.
The recalled product
- Product
- Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
- Manufacturer
- Acutus Medical Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 5
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 (1)
- Affected Lot Numbers/Expiration Date: 19101020 /October 2020
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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