ENSEAL X1 Tissue Sealer (2019-05-13)

Starting date:

May 13, 2019

Posting date:

May 31, 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-70061

Last updated: 2019-05-31

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  Reason
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  Affected products

Affected Products

ENSEAL X1 Tissue Sealer

Reason

Ethicon observed a reported incidence rate for harms associated with intraoperative bleeding that do not meet ethicon's performance standards. Several complaint reports have been received that indicate that the device is not achieving expected hemostasis.

Affected products