Boston Scientific Corporation: Medical Device Recall in 2015 - (Recall #: Z-2378-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.

Product Classification:

Class II

Date Initiated: July 31, 2015

Date Posted: August 19, 2015

Recall Number: Z-2378-2015

Event ID: 71849

Reason for Recall:

AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.

Status: Terminated

Product Quantity: total of 9 units

Code Information:

162185 162318

Distribution Pattern:

Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.

Voluntary or Mandated:

Voluntary: Firm initiated