Recall archive
17 recalls · page 1 of 1
Reported May 22, 2024
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details — The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
FDA (openFDA device enforcement)
Reported Feb 21, 2024
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details — The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details — Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Maquet Medical Systems USA
Matched: Brand · Product · Product details · Reason for recall — CARDIOHELP-i System was not properly tested to measure leakage current
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details — Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default…
FDA (openFDA device enforcement)
Reported Dec 13, 2023
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Medical Systems USA
Matched: Brand · Product · Product details — Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to…
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details — It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows…
FDA (openFDA device enforcement)
Reported Jun 7, 2023
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details — 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may…
17 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2023
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details · Reason for recall — Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result…
FDA (openFDA device enforcement)
Reported Sep 28, 2022
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details — The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details — Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to…
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand — There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination…
FDA (openFDA device enforcement)
Reported Nov 16, 2016
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details · Reason for recall — Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to…
FDA (openFDA device enforcement)
Reported Mar 9, 2016
Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular US Sales, LLC
Matched: Brand · Product · Product details · Reason for recall — MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0). The Extension Device is…
FDA (openFDA device enforcement)
Reported Jan 28, 2015
TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details · Reason for recall — The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg Up and Upper Leg Down are switched in…
FDA (openFDA device enforcement)
Reported Jun 18, 2014
Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details · Reason for recall — Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or several plastic fixation tabs can break, which can cause…
FDA (openFDA device enforcement)
Reported Nov 6, 2013
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
Matched: Brand · Product · Product details · Reason for recall — It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm,…
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up