Device recall

Z-3145-2026: Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069…

FDA device recall · Class II · Maquet Cardiopulmonary Gmbh

Key facts

Recall number (Z-number) Z-3145-2026
Recall event 99668
Product Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Product code DWF
Recalling firm Maquet Cardiopulmonary Gmbh
Recall class Class II
Status Open, Classified
510(k) numbers K131666
FEI number 3009507273

At a glance

  • 1–9 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)