Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Imperative Care Recalled by IMPERATIVE CARE INC Due to There is a potential for distal end of...

Date: August 13, 2021
Company: IMPERATIVE CARE INC
Status: Completed
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact IMPERATIVE CARE INC directly.

Affected Products

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.

Quantity: 3118 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About IMPERATIVE CARE INC

IMPERATIVE CARE INC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report