FDA recall Z-1768-2020

Product

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.

Distribution

US: CA,SC, AZ OUS: None

Key facts

Status

Terminated

Initiation date

2020-02-25

Report date

2020-04-29

Termination date

2021-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1768-2020