Class II — Potential Health Hazard

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

Pulsiocath PiCCO ProAQT Monitoring Kit Recalled by Pulsion Medical Inc Due to Internal testing and investigation of the packaging revealed...

Date: November 4, 2014
Company: Pulsion Medical Inc
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 Pulsion Medical Inc directly.

Affected Products

Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.

Quantity: 90 units

Why Was This Recalled?

Internal testing and investigation of the packaging revealed cracks and holes in primary packaging

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pulsion Medical Inc

Pulsion Medical Inc has 1 total recall tracked by RecallDetector.

Related Recalls

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