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