Recall Monitor
Health Products

Glidesheath Slender® Introducer Sheath

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Glidesheath Slender® Introducer Sheath
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Glidesheath Slender® Introducer Sheath000144187160-1060

Issue

Through post-market surveillance, we have received complaints for the guidewire not being able to pass through the needle. Through our investigation it was determined that a portion of the lot had the incorrect guidewire size. Terumo has received 84 complaints for this issue and no serious injuries. The probability of medically reversible or transient adverse health consequences is not likely. The situation is detectable at the time of use. There is no risk to patients who have used this lot. 1. Review your Glidesheath Slender inventory and immediately isolate lot number 0001441871.

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