Boston Scientific Scimed: Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). The stent is constrained within a 6F delivery system. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. An inner shaft, with two radiopaque markers, aids in the placement of the stent. The delivery system is compatible with 0.035 in. (0.89mm) guidewires. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. As the stent is exposed to body temperature it expands to appose the duct wall.

Recall number

Z-0440-06

Recalling firm

Boston Scientific Scimed

Product

Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). The stent is constrained within a 6F delivery system. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. An inner shaft, with two radiopaque markers, aids in the placement of the stent. The delivery system is compatible with 0.035 in. (0.89mm) guidewires. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. As the stent is exposed to body temperature it expands to appose the duct wall.

Status

Terminated

Initiated

2004-05-14

Posted

2006-01-25

Terminated

2007-01-23

Reason

One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct and the correct DFU is in the package.

Root cause

Other

Action

A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product.

Quantity

20

Distribution

Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Indonesia, Vietnam, New Zealand, Israel, Korea, Malaysia, Mexico, Philippines, Singapore, South Africa, Taiwan, Thailand, Turkey, Uruguay, Andean & Caaribbean Countries, Cyprus, Balkins, Puerto Rico, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Syria, Tunisia, Yemen, United Arib Emirates

Lot, serial or model codes

UPN # H7493894886070, lot # 6412353

510(k) numbers

["K032025"]

PMA numbers

not on file

Product code

FGE

Firm FEI

3002095335

Firm city

Maple Grove

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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