FDA recall Z-2364-2023

Product

UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO

Reason for recall

There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed.

Distribution

Nationwide Foreign: Japan, South Korea

Key facts

Status

Ongoing

Initiation date

2023-06-23

Report date

2023-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Denzlingen, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2364-2023