Sequestra 1000 System (2018-11-26)

Starting date:

November 26, 2018

Posting date:

January 8, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68702

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  Reason
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  Affected products

Affected products

Sequestra 1000 System

Reason

Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit. There were no (0) adverse reactions or harms associated with these complaints. Medtronic does not recommend any further actions for patients already treated with the affected devices. These patients should continue to be monitored in accordance with standard practice.

Affected products