Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
Reported: April 29, 2020 Initiated: February 25, 2020 #Z-1768-2020
Product Description
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, 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
- 108 units
- Distribution
- US: CA,SC, AZ OUS: None
- Location
- Carlsbad, CA
Frequently Asked Questions
What product was recalled? ▼
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly. Recalled by Acutus Medical Inc. Units affected: 108 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-1768-2020.
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