EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 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 issuing updated Instructions for Use (IFU) for the EXALT Model D Single-Use Duodenoscope, a sterile flexible video scope designed for use with the EXALT Controller. The update highlights a known risk of perforation associated with the device and provides best clinical practices for proper insertion, advancement, and removal of the scope.
Approximately 1,486 units of this device have been distributed worldwide, with 1,441 units in the US and 45 units in other countries including Australia, Canada, China, France, Germany, and many others. The recall affects all lots of the product. The source does not specify a remedy 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: 1486 units: US: 1,441; OUS: 45 Lot/code info: All lots GTIN: 08714729983514
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.