Recall Z-3145-2026— Maquet Cardiopulmonary Gmbh

Name: FDA recall Z-3145-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Class II · Ongoing

Class II FDA medical device recall by Maquet Cardiopulmonary Gmbh, initiated 2026-07-31. It names one FDA 510(k) clearance: K131666. Product: Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);. Reason: The packaging may not consistently maintain sterile barrier integrity..

Recalling firm: Maquet Cardiopulmonary Gmbh
Classification: Class II
Status: Ongoing
Initiated: 2026-07-31
Firm location: Rastatt, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K131666 — ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGMaquet Cardiopulmonary, AG·cleared 2013-07-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);

Reason for recall

The packaging may not consistently maintain sterile barrier integrity.

Data sourced from openFDA. This site is unofficial and independent of the FDA.