Spectranetics Corporation: Medical Device Recall in 2019 - (Recall #: Z-0576-2020)

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:

Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.

Product Classification:

Class II

Date Initiated: December 7, 2018

Date Posted: December 4, 2019

Recall Number: Z-0576-2020

Event ID: 84057

Reason for Recall:

The incorrect outer carton box was used for the product.

Status: Terminated

Product Quantity: 3 catheters

Code Information:

AngioSculpt PTCA lot #G18090030.

Distribution Pattern:

Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated