EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is updating the Instructions for Use (IFU) for the EXALT Model D Single-Use Duodenoscope, a sterile, single-use flexible video duodenoscope designed for use with the EXALT Controller. The update highlights the known risk of perforation associated with this device and provides best clinical practices for proper insertion, advancement, and removal to help minimize this risk.
The affected device has been distributed worldwide, including throughout the United States and in numerous countries including Canada, Australia, and most of Europe. A total of 538 units are involved in this recall across all lots (GTIN: 08714729995753). The source does not specify a remedy or recommended action for consumers or healthcare providers.
Written by software from the official notice below. Not reviewed by a lawyer.
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
Reason for recall: Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, IRELAND, Israel, Italy, Kuwait, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Unit. Arab Emir. Quantity: OUS: 538 units Lot/code info: All lots GTIN: 08714729995753
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.