Acutus Medical Recalls Rhythm Xience Guider Catheter Introducers Due to Foreign Material
Acutus Medical Inc is recalling 108 units of Rhythm Xience Guider Catheter Introducers because manufacturing defects may have left foreign material particulates 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 source text explicitly states that the defect could result in pulmonary embolism, which is a significant injury report, meeting the criteria for a Severe (4) rating.
Plain-English summary
Acutus Medical Inc is recalling 108 units of the Rhythm Xience Guider Catheter Introducer with Lancer Integrated Dilator/Transseptal Needle (Ref 112852). The recall affects specific lots with expiration dates in April, May, and June 2020. The 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. According to the source text, this defect could result in a range of 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 recall is classified as Class II by the FDA.
The recalled product
- Product
- Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
- Manufacturer
- Acutus Medical Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 108
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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