Public recall detail

Exalt Model D Single-Use Duodenoscope

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Recall Safety notice
Quick summary

Quick summary: Exalt Model D Single-Use Duodenoscope.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Exalt Model D Single-Use Duodenoscope.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBOSTON SCIENTIFIC CORPORATION
ProductExalt Model D Single-Use Duodenoscope
IssueMedical devices - Revised instructions for use
Recall classType II
IdentificationRA-63991

Affected products

ProductExalt Model D Single-Use Duodenoscope
LotAll lots.
ModelM00542420, M00542421, M0054242CE0, M0054242CE1
Serial numberAll lots.
DescriptionExalt Model D Single-Use Duodenoscope

Issue

Due to the higher observed occurrence of esophageal perforations compared to the rate reported in literature, a product advisory is recommended to make users aware of the events and to reiterate and supplement the warnings and directions related to perforations in the product labeling, and to communicate the intent to update the instructions for use with this information. Recall start date: Mar 3, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesBoston Scientific Corporation 300 Boston Scientific Way, Marlborough, Massachusetts United States, 01752
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63991
Background{}
CompaniesBoston Scientific Corporation 300 Boston Scientific Way, Marlborough, Massachusetts United States, 01752
AudiencesGeneral public Health professionals Hospitals
Source updated2022-03-14

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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