FDA recall Z-2577-2021

Product

Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.

Reason for recall

There is a potential for distal end of catheters to fracture and become detached.

Distribution

US nationwide distribution.

Key facts

Status

Completed

Initiation date

2021-08-13

Report date

2021-10-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Campbell, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2577-2021