Boston Scientific Corporation: Medical Device Recall in 2017 - (Recall #: Z-2645-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)

Product Classification:

Class II

Date Initiated: December 15, 2016

Date Posted: July 12, 2017

Recall Number: Z-2645-2017

Event ID: 76772

Reason for Recall:

A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.

Status: Terminated

Product Quantity: 39 boxes of 5 (195 units)

Code Information:

Lot: 00112758, Use by 2018-05-11

Distribution Pattern:

CA, FL, KY, MO, NM, OK, OR, PA, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated