Boston Scientific Corporation: 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.

Agency Publication Date: May 13, 2022

Affected Products

Product: 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.

All lots GTIN: 08714729983514

Product: 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.

All lots GTIN: 08714729993605

Product: 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.

All lots GTIN: 08714729995746

Product: 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.

All lots GTIN: 08714729995753

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89931

Status: Active

Manufacturer: Boston Scientific Corporation

Manufactured In: United States

Units Affected: 4 products (1486 units: US: 1,441; OUS: 45; 6,946 units. US: 6,916; OUS: 30; OUS: 1,094 units; OUS: 538 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

All lots GTIN: 08714729983514

All lots GTIN: 08714729993605

All lots GTIN: 08714729995746

All lots GTIN: 08714729995753