Boston Scientific Corporation: Device Recall

Recall Details

Recall Number

Z-3149-2024

Classification

Class II

Product Type

Device

Recalling Firm

Boston Scientific Corporation

Status

Ongoing

Date Initiated

07/18/2024

Location

Maple Grove, MN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

10 units

Reason for Recall

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

Product Description

Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.

Distribution Pattern

US, Colombia, Philippines, Russia

Other Recalls by Boston Scientific Corporation

• Class I: Dangerous 12/19/2025
  Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
• Class I: Dangerous 12/19/2025
  Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
• Class I: Dangerous 12/19/2025
  Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
• Class I: Dangerous 12/19/2025
  Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
• Class I: Dangerous 12/19/2025
  Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

View all recalls by Boston Scientific Corporation →