EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 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 for the EXALT Model D Single-Use Duodenoscope, a sterile flexible video device used with the EXALT Controller. The update highlights the known risk of perforation associated with the device and provides best clinical practices for its insertion, advancement, and removal. The device has been distributed worldwide, including across the United States and numerous countries in Europe, Asia, the Middle East, Africa, and Oceania, with approximately 1,094 units affected across all lots.
The recall affects all lots of the product, identified by GTIN 08714729995746. The source document does not specify a remedy or any actions that affected consumers should take.
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: 1,094 units Lot/code info: All lots GTIN: 08714729995746
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.