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