Sherpa NX Active Guide Catheter (2019-04-11)

Starting date:

April 11, 2019

Posting date:

May 3, 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-69830

Last updated: 2019-05-03

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  Reason
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  Affected products

Affected Products

Sherpa NX Active Guide Catheter

Reason

Medtronic determined that the recalled device was assessed to have an unacceptable potential for a failure mode of extensive loss of the distal segment outer material, with resulting exposure of the underlying stainless-steel braid wires after insertion into the body. The potential patient risks related to this issue include surgical intervention, dissection, non-occluding embolism, occlusion, prolonged procedure, and cerebrovascular accident.

Affected products