Public recall detail

Sureform 45/60

medium
Recall Safety notice
Quick summary

Quick summary: Sureform 45/60.

Recommended action

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Recall details

Quick summary: Sureform 45/60.

Official details

Affected product details

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

BrandIntuitive Surgical Inc.
ProductSureform 45/60
IssueMedical devices - Performance
Recall classType II
IdentificationRA-64037

Affected products

ProductSureform 45
LotT91211122, L90211027, T90211122, T90211201
Model480445, 480545
Serial numberT91211122, L90211027, T90211122, T90211201
DescriptionSureform 45
ProductSureform 60
LotL93220105, L90211213, L90211013, L91211004, T91211102
Model480460
Serial numberL93220105, L90211213, L90211013, L91211004, T91211102
DescriptionSureform 60

Issue

A review of complaints on Sureform PNs 480445, 480545, 480460 was done to determine rate of harm due to tissue pushout events. This action was completed as part of an internal capa. Sureform complaint data from October 1, 2019 through September 30, 2021 was reviewed. Overall rate of harm associated with bleeding (tissue pushout events) of critical severity exceeds the predicted likelihood of harm as documented. Recall start date: Mar 17, 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 - General and plastic surgery
CompaniesIntuitive Surgical Inc. 1266 Kifer Road, Sunnyvale, California United States, 94086
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64037
Background{}
CompaniesIntuitive Surgical Inc. 1266 Kifer Road, Sunnyvale, California United States, 94086
AudiencesGeneral public Health professionals Hospitals
Source updated2022-04-04

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

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