Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations Recalled by Invivo Corporation Due to Intermittent communication between the host system and the...

Date: August 18, 2017
Company: Invivo Corporation
Status: Terminated
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 Invivo Corporation directly.

Affected Products

Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.

Quantity: 4,535

Why Was This Recalled?

Intermittent communication between the host system and the FlexCardio

Where Was This Sold?

This product was distributed to 48 states: AL, AK, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, DC

Affected (48 states)Not affected

About Invivo Corporation

Invivo Corporation has 19 total recalls tracked by RecallDetector.

Related Recalls

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