HEMOSPRAY ENDOSCOPIC HEMOSTAT (2019-07-24)

Starting date:

July 24, 2019

Posting date:

July 30, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70589

Last updated: 2019-07-30

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  Reason
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  Affected products

Affected Products

HEMOSPRAY ENDOSCOPIC HEMOSTAT

Reason

This product is being recalled because Cook has received eight (8) complaints of the Hemospray device being unable to spray powder due to misassembly of devices. This has been reported to have led to an inability to achieve hemostasis, and in one case, the patient was transferred to surgery. There is also a potential risk of death if hemostasis is unable to be achieved in emergent cases. As stated above, the devices may not spray powder resulting in an inability to achieve hemostasis

Affected products