FDA recall Z-1770-2020

Product

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.

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-1770-2020