Isomed Refill Kit (2019-11-15)

Starting date:

November 15, 2019

Posting date:

December 20, 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-71925

Last updated: 2019-12-20

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  Reason
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  Affected products

Affected Products

Isomed Refill Kit

Reason

Medtronic is voluntarily issuing a safety notification related to availability of the Isomed Catheter Access Port (CAP) and refill kits. The inventory for the model 8555 refill kit, used with the Isomed pump, is expected to be depleted in the next 3-5 months. In order ensure patients implanted with a medtronic Msomed drug infusion pump can continue to receive therapy, medtronic is providing instructions for performing cap and refill procedures.

Lack of ability to refill the pump or manage patient therapy due to the unavailability of accessory kits can result in sudden cessation of therapy. Sudden cessation of drug infusion therapy may result in the return of underlying symptoms and/or withdrawal symptoms, which can lead to a life-threatening condition.

Affected products