IMPERATIVE CARE INC recalls Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm),…

Recall date

August 13, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2577-2021

FDA classification

Class I

Brand / firm

IMPERATIVE CARE INC

Sold / distributed

US nationwide distribution.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.