EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duo
Summary
The FDA issued a Class II for EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: by Boston Scientific Corporation. Reason: Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practi.
Details
Source
Device Recall
External ID
Z-1082-2022
Action Date
2022-05-25
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: All lots GTIN: 08714729995753
Quantity Affected: OUS: 538 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-03
Company
Marlborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1082-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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