Maquet Medical Systems recalls
14 official recalls and safety alerts involving Maquet Medical Systems since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Maquet Medical Systems or the relevant agency.
- 2024-05-22
USMaquet Medical Systems USA recalls CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
FDA · DeviceMaquet Medical Systems USAUS Nationwide distribution in the states of NJ & TX.Official notice →- 2024-02-21
- US
Maquet Medical Systems USA recalls BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
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 result in inflammation, sepsis, or infection.
- 2024-02-14
- US
Maquet Medical Systems USA recalls Bubble Sensor (REF: 70105.5720)
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
FDA · DeviceMaquet Medical Systems USAAZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.Official notice → - US
Maquet Medical Systems USA recalls BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or…
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms:…
FDA · DeviceMaquet Medical Systems USAWorldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC,…Official notice → - 2023-12-27
- US
Maquet Medical Systems USA recalls Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be…
FDA · DeviceMaquet Medical Systems USADomestic distribution Nationwide. Foreign distribution to Argentina,…Official notice → - US
Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the…
CARDIOHELP-i System was not properly tested to measure leakage current
FDA · DeviceMaquet Medical Systems USANationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan,…Official notice → - 2023-12-20
- US
Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the…
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the…
FDA · DeviceMaquet Medical Systems USAWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2023-12-13
- US
Maquet Medical Systems USA recalls CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide…
Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and…
FDA · DeviceMaquet Medical Systems USAUS Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC,…Official notice → - 2023-11-15
- US
Maquet Medical Systems USA recalls Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
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 the nut bolt to break off from the slide rail plate with slight manual…
- 2023-06-07
- US
Maquet Medical Systems USA recalls QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis,…
- US
Maquet Medical Systems USA recalls QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may…
- 2023-03-08
- US
Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078.…
Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.
FDA · DeviceMaquet Medical Systems USAWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2022-09-28
- US
Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or…
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
FDA · DeviceMaquet Medical Systems USAWorldwide distribution - US Nationwide and the countries Canada and Australia.Official notice → - 2022-04-13
- US
Maquet Medical Systems USA recalls Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump…
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 not open or, if the locking pin is fully disengaged from the assembly,…
FDA · DeviceMaquet Medical Systems USAUS Nationwide Distribution: FL, KY, NH, NJ, NY, PA, TX, VA Foreign: Belgium,…Official notice →