Help us improve our website

Health product recall

PROXIMATE ILS Intraluminal Stapler, Endopath ILS Endoscopic Circular Stapler (2019-03-28)

Starting date:
March 28, 2019
Posting date:
April 12, 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-69566

Last updated: 2019-04-12

Affected Products

  1. PROXIMATE ILS Intraluminal Stapler with detachable head
  2. Endopath ILS Endoscopic Circular Stapler with low profile anvil

Reason

Through investigation of complaints and returned products, we have confirmed occurrence of uncut washers and malformed staples with our ILS circular staplers, which can compromise staple line integrity. If a problem with the staple line is not adequately addressed or is not recognized, there is a potential risk of postoperative anastomotic leak, gastrointestinal injury, hemorrhage, or hemorrhagic shock.

Affected products

  1. PROXIMATE ILS Intraluminal Stapler with detachable head

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

CDH21A
CDH25A
CDH29A
CDH33A
SDH21A
SDH25A
SDH29A
SDH33A

Companies
Manufacturer

ETHICON ENDO-SURGERY, LLC.

475 CALLE C

GUAYNABO

00969

PUERTO RICO

B. Endopath ILS Endoscopic Circular Stapler with low profile anvil

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

ECS21A
ECS25A
ECS29A
ECS33A

Companies
Manufacturer

ETHICON ENDO-SURGERY, LLC.

475 CALLE C

GUAYNABO

00969

PUERTO RICO