The Recall Desk
HighFDA (Devices)·Z-1649-2016·Announced 2016-05-18

Medtronic Recalls Kangaroo Connect Enteral Feeding Pumps Due to Alarm Failure

Medtronic is recalling 145 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, posing a risk to patients in hospital settings.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure of a safety alarm (occlusion) in a medical device used for patient nutrition, which poses a risk of harm, but the source does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic is recalling 145 units of the Kangaroo Connect Enteral Feeding Pump (Item Number: 584400) due to a defect in the occlusion alarm system. The device is intended to provide enteral nutrition to patients in hospital and acute care settings. The recall was initiated because the occlusion alarms may fail to alarm when an occlusion occurs.

The affected units were distributed worldwide, including in the USA, Australia, Canada, France, and Singapore. The specific serial numbers for the 145 affected units are listed in the official recall documentation. No specific dates of distribution or manufacturing are provided in the source text.

Healthcare facilities and consumers should stop using the affected pumps immediately and contact Medtronic for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Manufacturer
Medtronic
Affected units
145

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Medtronic under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →