Boston Scientific Corporation: Medical Device Recall in 2019 - (Recall #: Z-1395-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.

Product Classification:

Class II

Date Initiated: April 8, 2019

Date Posted: May 29, 2019

Recall Number: Z-1395-2019

Event ID: 82691

Reason for Recall:

Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.

Status: Terminated

Product Quantity: 8 (OUS)

Code Information:

Serial Number: 21302772, 21302803, 21302784, 21302930, 21302967, 21302968, 21302985, 21303026

Distribution Pattern:

Worldwide distribution to Australia, Belgium, Brazil, Chile, Colombia, Egypt, France, Germany, Great Britain, India, Indonesia, Iran, Italy, Lebanon, Malaysia, Mexico, Romania, Russia Fed., South Africa, South Korea, Spain, Taiwan, United Arab Emirates and Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated