EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 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 recalling the EXALT Model D Single-Use Duodenoscope, a sterile flexible video scope intended for use with the EXALT Controller. The recall affects 6,946 units distributed worldwide, including 6,916 units in the United States and 30 units internationally across countries including Canada, Australia, and numerous European and Middle Eastern nations. All lots with GTIN 08714729993605 are affected.
The company is updating the Instructions for Use to highlight the known risk of perforation associated with the device and to provide best clinical practices for proper insertion, advancement, and removal. The recall notice does not specify a remedy or remedial action for affected consumers.
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: 6,946 units. US: 6,916; OUS: 30 Lot/code info: All lots GTIN: 08714729993605
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.