Terminated

HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support.

FDA Recall Z-1690-2015 · Posted 2015-05-28

Recalling FirmMaquet Cardiovascular Us Sales, Llc

Recall StatusTerminated

Product CodeDTQ

Date Initiated2015-03-05

Date Terminated2019-01-18

Product Quantity10, 199 units

Reason for Recall

A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.

Firm Action

Maquet sent a "Field Safety Notice" accompanied by a Response Form to their affected customers on 3/5/2015 via FedEx. The Field Safety Notice identified the affected products/Part numbers and actions to be taken by the user. The customers were asked to complete the Field Safety Notice Response Form to acknowledge that they have received the notice. The completed notice can be faxed to 1-973-396-3607 or sent via email to [email protected]. For any questions, customers can contact their Maquet Sales Representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, South Korea, Latvia, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia Montenegro, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and Uruguay

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102726CARDIOHELP SYSTEMMaquet Cardiopulmonary, AG · 2011-04-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.