Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2013 - (Recall #: Z-2262-2013)

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:

QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

Product Classification:

Class II

Date Initiated: August 15, 2013

Date Posted: October 2, 2013

Recall Number: Z-2262-2013

Event ID: 66049

Reason for Recall:

The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.

Status: Terminated

Product Quantity: 1,182 units

Code Information:

QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult catalog number VKMO 70000, lot # 70082663 QUADROX-i Adult catalog number VKMO 71000, lot # 70083974

Distribution Pattern:

Worldwide Distribution, including Nationwide (US) and foreign countries.

Voluntary or Mandated:

Voluntary: Firm initiated