medical Class II Updated 2020-04-29

Acutus Medical Inc recalls Rhythm Xience Guider Catheter Introducer with Lancer Intergr

Recalled Product

Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly


Hazard / Issue

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.

Issued by

FDA

Affected States: CA, SC, AZ
Lot/Code Info: Affected Lot Numbers/Expiration Date: 19040503 /April 2020 19052007 /May 2020 19061317 /June 2020
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →