Device recall

Z-0031-04: Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter…

FDA device recall · Class II · Boston Scientific Scimed

Key facts

Recall number (Z-number) Z-0031-04
Recall event 27231
Product Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Product code LOX
Recalling firm Boston Scientific Scimed
Recall class Class II
Status Terminated
Termination date Oct 24, 2005
PMA numbers P860019
FEI number 3002095335

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)