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EXALT Model D recallZ-1081-2022 · Boston Scientific Corporation · initiated Mar 3, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

Boston Scientific notified US and US Territories from March 3rd through March 17th, via hand delivery, FedEx, or e-mail . OUS Consignees were notified from March 3rd through March 10th, via hand delivery, courier, or e-mail. Additional US Consignees located in the US and US Territories were notified from April 7, 2022, through April 13, 2022. Additional OUS Consignees were notified on April 7, 2022. Immediate Action Required EXALT Model D Single-Use Duodenoscope. Letter states. Customers to whom hand-delivery is not possible within a ten-day timeframe will receive the letter through other means (e.g., courier, e-mail). The notification instructs the account to review the content of the IFU updates, share the information and post it in a visible location near the product, and to complete the Acknowledgment Form to confirm receipt of the notification. After all applicable regulatory approvals are obtained, the updated IFUs will be packaged with EXALT Model D Single-Use Duodenoscopes. An updated IFU will be available at https://www.bostonscientific.com/elabeling in the US. ***UPDATE 4/29/22: BSC implemented the updated IFU for US customers (an electronic-only IFU published to BSC's website) on March 21 , 2022. This electronic-only IFU supports UPNs M00542420 and M00542421 (the UPNs intended primarily for US distribution). BSC will implement the updated IFU for OUS customers (in UPNs M0054242CE0 and M0054242CE1 , the UPNs intended primarily for OUS distribution) following language translations and receipt of paper IFU inventory, estimated for May 2022.

Recall details

Recall number
Z-1081-2022
Status
Open, Classified
Initiated by the company
Mar 3, 2022
Recalling firm
Boston Scientific Corporation
Quantity
OUS: 1,094 units
Product code
FDT
FDA submissions
K193202
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.

Product description

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.

Code information (models, lots, serial numbers)

All lots GTIN: 08714729995746

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 89931).

Sources and updates

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