Rhythm Xience Flextra Steerable Introducer with Lancer recall: Particulate Matter
Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
Why was Rhythm Xience Flextra Steerable Introducer with Lancer 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Affected Lot Numbers/Expiration Date: 19052006/ May 2020 19061318/ June 2020
- Product
- Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
- Recalling firm
- Acutus Medical Inc
- Quantity
- 30 units
- Distribution
- US: CA,SC, AZ OUS: None
- Recall date
- April 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)