Acutus Medical Recalls Rhythm Xience Flextra Steerable Introducers Due to Foreign Material
Acutus Medical Inc is recalling 30 units of Rhythm Xience Flextra Steerable 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 constitutes a significant injury report under the severity rubric for Class II recalls.
Plain-English summary
Acutus Medical Inc is recalling 30 units of the Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle (REF: 122852, Sterile EO, RxOnly). The affected lots are 19052006 (May 2020) and 19061318 (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. The FDA has classified this as a Class II recall.
The presence of foreign material could result in a range of events, from procedure delay to pulmonary embolism. Healthcare providers and patients should contact Acutus Medical Inc for further instructions regarding the affected devices.
The recalled product
- Product
- Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
- Manufacturer
- Acutus Medical Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 30
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: 19052006/ May 2020 19061318/ June 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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