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URGENT: VOLUNTARY MEDICAL DEVICE RECALL

Jun 15, 2026

Device: Glidesheath Slender® Introducer Sheath
Code: 60-1060
Lot Number: 0001441871

Dear Valued Customer,                                                                    

The purpose of this letter is to notify consignees that Terumo Medical Corporation is voluntary recalling one lot of GlideSheath Slender® due to the incorrect guidewire included in some GlideSheath Slender® Introducer Sheath packages. 

Description of the Problem:

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. 

Risk to Health:

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.    

Corrective Action:

Terumo is conducting a thorough root cause investigation to determine the appropriate actions to eliminate future occurrences. 

Devices included:

Device: GlideSheath Slender Introducer Sheath
Code: 60-1060
Lot Number: 0001441871
UDI-PI: (17)280501(10)0001441871

Actions To Be Taken by Customer:

1. Review your Glidesheath Slender Inventory and immediately isolate lot number 0001441871.   
2. If devices have been transferred to another facility, please provide them with a copy of this notification and instruct them to follow the actions in this section. 
3. Complete Appendix 1 for the number of units in your control to be returned to Terumo.  The form is required even if you do not have a product on hand. 
4. Contact tmccustomer.admin@terumomedical.com to initiate the return process. 

Please be assured that we take the safety and quality of our products very seriously and remain committed to supporting you with high quality products.  If you have additional questions, please reach out to your Terumo Representative or contact us at tmccustomer.admin@terumomedical.com. 

On behalf of Terumo Medical Corporation

Kimberly Feitl
Vice President, Quality

VOLUNTARY MEDICAL DEVICE RECALL NOTICE

Appendix 1: Recall Notice Acknowledgement Form
2026-TMC-001

Account Information:

Customer Name:

 

Customer Address:

 

Customer Telephone Number:

 

Customer e-mail Address:

 

To be completed by the customer:

Quantity of Product in My Facility:

 

Quantity of Product Being Returned:

 

Lot #s included:

 

By signing below, I acknowledge:
· Receipt of the recall notice and confirm that I understand the contents.
· I have communicated the information to users in my organization or other organizations I transferred products to.
· All products in my facility have been isolated and are being returned. 

Name (Print):

 

Signature:

 

Date:

 


Please return completed form to Market_Actions-TMC@terumomedical.com.

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