Formula 418 Renal Balloon-Expandable Stent (2020-04-14)

Starting date:

April 14, 2020

Posting date:

May 1, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72947

Last updated: 2020-05-01

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  Reason
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  Affected products

Affected Products

Formula 418 Renal Balloon-Expandable Stent

Reason

Cook Medical Inc. has received complaints on five devices from this lot where the stent dislodged from the balloon delivery system prior to deployment. Due to the number of complaint devices from this product lot, Cook Medical Inc. is initiating a lot specific voluntary recall.

Affected products