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…
Read the official notice →- Date
- 2023-12-27
- Country
- United States
- Brand
- Maquet Medical Systems
- Product
- Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
- Classification
- Class II
- Units
- Domestic distribution Nationwide. Foreign distribution to Argentina,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Maquet Medical Systems recalls
- 2024-02-21
USMaquet 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
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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 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 →
Other drugs & medical recalls in the United States
- 2024-01-03
- US
GlaxoSmithKline LLC recalls ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only,…
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
- 2023-12-27
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Stryker Spine recalls LITe Decompression Snake Arm, REF 48080230
Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
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Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to…
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of…
FDA · DeviceSiemens Healthcare Diagnostics IncNationwide with Worldwide Distribution to: Albania Algeria Angola Argentina…Official notice → - US
Abbott Laboratories recalls Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01.…
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
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Zeus Scientific, Inc. recalls ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
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Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS…