Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-0758-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190

Product Classification:

Class II

Date Initiated: November 16, 2020

Date Posted: January 6, 2021

Recall Number: Z-0758-2021

Event ID: 86880

Reason for Recall:

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

Status: Ongoing

Product Quantity: 458 units

Code Information:

GTIN 08714729423768: Lots 25928323, 25928324. GTIN 08714729423829: Lots 25928325, 25928326, 25933063, 25933064, 25933065. GTIN 08714729772743: Lot 25965814. GTIN 08714729765837: Lot 25966020.

Distribution Pattern:

Distribution US nationwide and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated