Boston Scientific Corporation: Medical Device Recall in 2019 - (Recall #: Z-0852-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Product Classification:

Class II

Date Initiated: December 19, 2018

Date Posted: February 27, 2019

Recall Number: Z-0852-2019

Event ID: 81863

Reason for Recall:

A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.

Status: Terminated

Product Quantity: 49 units

Code Information:

Material Number (UPN) H749M3004A0, Batch Number 21558994, Expiration Date 11/30/2019

Distribution Pattern:

Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY.

Voluntary or Mandated:

Voluntary: Firm initiated