Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
Reported: April 29, 2020 Initiated: February 25, 2020 #Z-1770-2020
Product Description
Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
Reason for Recall
It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Details
- Recalling Firm
- Acutus Medical Inc
- Units Affected
- 30 units
- Distribution
- US: CA,SC, AZ OUS: None
- Location
- Carlsbad, CA
Frequently Asked Questions
What product was recalled? ▼
Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly. Recalled by Acutus Medical Inc. Units affected: 30 units.
Why was this product recalled? ▼
It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2020. Severity: Moderate. Recall number: Z-1770-2020.
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