Maquet Cardiovascular Us Sales, Llc
Complete recall history across all FDA and CPSC categories — 62 total recalls
Maquet Cardiovascular Us Sales, Llc 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 (62)
FDA medical device enforcement actions by Maquet Cardiovascular Us Sales, Llc. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 20, 2020 | HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/... | The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to bre... | Class II |
| Nov 20, 2020 | HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product ... | The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to bre... | Class II |
| Sep 30, 2020 | Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to mo... | The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC... | Class II |
| Sep 24, 2020 | Yuno II Mobile Operating Table - Product Usage: support and position the pati... | Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and el... | Class II |
| Sep 24, 2020 | Yuno Mobile Operating Table - Product Usage: Intended for support and positio... | Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and el... | Class II |
| Aug 7, 2020 | Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: In... | Instruction For Use (IFU) references incorrect serial number of 90437000. It ... | Class III |
| Jun 18, 2020 | Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxy... | Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use wi... | Class II |
| Feb 20, 2020 | Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 | A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a ... | Class II |
| Feb 10, 2020 | Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and... | Potential leakage that may occur due to ruptured spot welds in the chamber, c... | Class II |
| Jan 16, 2020 | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Produ... | Due to a missing water intake for Deionized water on the Getinge 46-Series Wa... | Class III |
| Jan 16, 2020 | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Produ... | Due to a missing water intake for Deionized water on the Getinge 46-Series Wa... | Class III |
| Dec 3, 2019 | Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. ... | A loose ODU plug / Coaxial cable connection may result in fluctuating flow va... | Class II |
| Jul 11, 2019 | Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-H... | The sets are configured with quick connectors that have been assembled in rev... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:V... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: V... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:V... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VL... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VL... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 28, 2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: ... | Potential that the coating of the light head forks on the VOLISTA Surgical Li... | Class II |
| May 20, 2019 | Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 P... | Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series ... | Class II |
| May 20, 2019 | Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Pr... | Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series ... | Class II |
| May 6, 2019 | GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 ... | User may suffer an electric shock when coming in contact with the exposed ele... | Class II |
| Feb 8, 2019 | Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardio... | Upon servicing the gearwheel in the Emergency Drive the gearwheel may have be... | Class I |
| Oct 25, 2018 | QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000... | There is a potential for blood leakage at the blood inlet connector when usin... | Class I |
| Oct 25, 2018 | QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10... | There is a potential for blood leakage at the blood inlet connector when usin... | Class I |
| Sep 27, 2016 | Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temper... | There is the potential for contaminated water to enter parts of the Heater-Co... | Class II |
| Aug 12, 2016 | The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecti... | Post Market Surveillance cases reported to Maquet showing instances in which ... | Class II |
| Feb 23, 2016 | Custom Tubing Packs Custom tubing pack for oxygenators | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the po... | Class II |
| Feb 23, 2016 | HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the po... | Class II |
| Feb 23, 2016 | QUADROX-i oxygenators Custom tubing packs for the oxygenator | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the po... | Class II |
| Feb 23, 2016 | Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the po... | Class II |
| Jan 7, 2016 | Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, ... | MAQUET Medical Systems USA is initiating a field action for correction of the... | Class II |
| Dec 10, 2015 | Flow-i Anesthesia System Product Usage: The indication for the Flow-i Ane... | Electrical issues in the control, monitoring or panel sub-systems, caused by ... | Class I |
| Nov 13, 2015 | Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W ... | Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop ... | Class II |
| Aug 17, 2015 | Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacture... | Two serious thromboembolic events were reported involving the Adjustable Posi... | Class II |
| Aug 17, 2015 | Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Ma... | Two serious thromboembolic events were reported involving the Adjustable Posi... | Class II |
| Jun 10, 2015 | Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Ar... | There is a potential issue that could result to collision between the C-arm o... | Class II |
| May 29, 2015 | The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light syst... | Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light System... | Class II |
| Apr 2, 2015 | FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use ... | In some Flow-i Anesthesia Systems, patient cassette can get dislodged which c... | Class I |
| Mar 5, 2015 | HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Produc... | A potential issue was detected that could result in blood leakage from the ga... | Class II |
| Mar 5, 2015 | Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox... | A potential issue was detected that could result in blood leakage from the ga... | Class II |
| Mar 2, 2015 | The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part numb... | Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and ... | Class II |
| Jan 12, 2015 | Servo-I ventilator system CO2 analyzer. Part number 65 23 588. | A calibration problem was detected in a specific number of the Servo-I ventil... | 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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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