Health product recall

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

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

ENSEAL X1 Tissue Sealer

Lot or serial number

All lots.

Model or catalog number
  • NSLX125C
  • NSLX137C
  • NSLX145C
Companies
Manufacturer
Ethicon Endo-Surgery, LLC
475 CALLE C
GUAYNABO
00969
PUERTO RICO