Maquet Medical Systems USA

Complete recall history across all FDA and CPSC categories — 40 total recalls

Maquet Medical Systems USA appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (40)

FDA medical device enforcement actions by Maquet Medical Systems USA

Date Product Reason Class
Apr 15, 2024 CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. The firm identified that the measured patient leakage current in some devices... Class II
Jan 16, 2024 Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 7... The Emergency Priming Line, a component of the HLS Set, may have a compromise... Class II
Jan 16, 2024 BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078.... The Emergency Priming Line, a component of the HLS Set, may have a compromise... Class II
Jan 8, 2024 BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 70... Nonconformities at their seal could potentially compromise the sterile barrie... Class II
Jan 8, 2024 BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 70... Nonconformities at their seal could potentially compromise the sterile barrie... Class II
Dec 28, 2023 Bubble Sensor (REF: 70105.5720) The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life ... Class II
Nov 14, 2023 CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide ... CARDIOHELP-i System was not properly tested to measure leakage current Class III
Nov 13, 2023 Venous probe connection cable (REF 701069333 and 701048804) used with the Car... Firm received complaints of breaks in the insulation, shielding, or wires of ... Class II
Nov 6, 2023 CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxid... Certain factory settings for the device were incorrectly described in the IFU... Class II
Oct 12, 2023 Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbe... It was found that the fixation (weld) employed by the supplier of the nut bol... Class II
Oct 10, 2023 CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOH... Product removal due to possible blocking or impairment of the CARDIOHELP Emer... Class I
May 18, 2023 HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypas... 1. An accessory may be improperly placed during packaging, causing creases an... Class II
May 18, 2023 BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary by... 1. An accessory may be improperly placed during packaging, causing creases an... Class II
May 18, 2023 QUADROX-iR, used during cardiopulmonary bypass Model ... Product packaging may exhibit small pinholes which may not be visible to the ... Class II
May 18, 2023 Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass M... Product packaging may exhibit small pinholes which may not be visible to the ... Class II
May 18, 2023 Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Mo... 1. An accessory may be improperly placed during packaging, causing creases an... Class II
May 18, 2023 QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model ... 1. An accessory may be improperly placed during packaging, causing creases an... Class II
May 18, 2023 QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model ... Product packaging may exhibit small pinholes which may not be visible to the ... Class II
May 18, 2023 QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model ... 1. An accessory may be improperly placed during packaging, causing creases an... Class II
May 18, 2023 QUADROX-iR, used during cardiopulmonary bypass Model ... 1. An accessory may be improperly placed during packaging, causing creases an... Class II
May 18, 2023 BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass ... 1. An accessory may be improperly placed during packaging, causing creases an... Class II
May 18, 2023 QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model ... Product packaging may exhibit small pinholes which may not be visible to the ... Class II
May 18, 2023 QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model ... Product packaging may exhibit small pinholes which may not be visible to the ... Class II
May 18, 2023 QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model ... Product packaging may exhibit small pinholes which may not be visible to the ... Class II
May 18, 2023 QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model ... 1. An accessory may be improperly placed during packaging, causing creases an... Class II
May 18, 2023 BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary by... 1. An accessory may be improperly placed during packaging, causing creases an... Class II
May 18, 2023 QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model ... 1. An accessory may be improperly placed during packaging, causing creases an... Class II
May 18, 2023 QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model ... Product packaging may exhibit small pinholes which may not be visible to the ... Class II
May 18, 2023 QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model ... Product packaging may exhibit small pinholes which may not be visible to the ... Class II
Feb 13, 2023 BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS ... Firm has initiated a removal of the product due to insufficient evidence of p... Class II
Jul 22, 2022 BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potenti... Class II
Jul 22, 2022 BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potenti... Class II
Jul 22, 2022 BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potenti... Class II
Jul 22, 2022 BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potenti... Class II
Feb 18, 2022 Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood ... Potential for a loose cylindrical pin on the Transport Guard that may result ... Class II
Jul 14, 2021 Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water ... There is the potential for contaminated water to enter parts of the Heater-Co... Class II
Oct 5, 2016 Accessory Adapter Part number 600525A0 Product Usage: designed for the mo... Maquet Inc. is initiating a voluntary field action on the Accessory Adapter p... Class II
Aug 21, 2014 TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR In... The wrong movement results on the MAGNUS OR table. The button commands on the... Class II
Apr 16, 2014 Maquet PowerLED 700. Product Usage; To provide illumination to the surgi... Maquet has identified an issue with the Maquet PowerLED 700 (certain serial n... Class II
Sep 12, 2013 MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manuf... It has come to the attention of MAQUET that in certain rare instances, the CA... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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