Boston Scientific Corporation: Medical Device Recall in 2013 - (Recall #: Z-1673-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.

Product Classification:

Class II

Date Initiated: May 28, 2013

Date Posted: July 17, 2013

Recall Number: Z-1673-2013

Event ID: 65317

Reason for Recall:

Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

Status: Terminated

Product Quantity: 15 units

Code Information:

Lot Number: 15982017, 15963887, 16034014

Distribution Pattern:

Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated