Public recall detail

Chameleon™ PTA Balloon Catheter

2024-09-26

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Recall Safety notice
Quick summary

Quick summary: Chameleon™ PTA Balloon Catheter. Date: 2024-09-26.

Recommended action

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

Recall details

Quick summary: Chameleon™ PTA Balloon Catheter. Date: 2024-09-26.

Official details

Affected product details

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

BrandCOVIDIEN LLC
ProductChameleon™ PTA Balloon Catheter
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76207

Affected products

ProductChameleon™ PTA Balloon Catheter
LotMore than 10 numbers, contact manufacturer.
ModelCH07-40-75US CH12-40-75US CH08-40-75US CH06-40-75US CH05-40-75US CH10-40-75US
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionChameleon™ PTA Balloon Catheter

Issue

Specific lots of the device failed to meet in-house balloon pressure testing. There were no serious patient injuries or deaths reported. While not observed or reported, additional potential risks or harms may include delay to treatment, hemorrhaging, blood loss, bleeding, or perforation of vessels. The most foreseeable sequence of events would be balloon rupture during inflation while under close monitoring and traditionally direct fluoroscopic visualization, resulting in careful removal of the malfunctioned device and replacement with a new balloon catheter for procedure completion. Recall start date: September 19, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesCovidien LLC 15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76207
Background{}
CompaniesCovidien LLC 15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
AudiencesHealthcare
Source updated2024-09-26

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

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