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Safety Reports: Medical Devices

Updated:

Boston Scientific Corporation LOTUS Edge™ Aortic Valve System - recalled due to Delivery System Issues Potential inability to release the delivery system, USA

3 years ago •source fda.gov • details

Recall notice

Company name: Boston Scientific Corporation
Brand name: LOTUS Edge™ Aortic Valve System
Product recalled: LOTUS Edge™ Aortic Valve System
Reason of the recall: Delivery System Issues Potential inability to release the delivery system
FDA Recall date: January 11, 2021
Recall details: Boston Scientific Corporation (NYSE: BSX) has… See more

#medicaldevices #us

321

Sigma Spectrum Infusion Pumps - recalled due to deviations from the specified cleaning methods may impair infusion pump, USA

3 years ago •source fda.gov • details

Recall notice

Company name: Baxter International Inc.
Brand name: Sigma Spectrum
Product recalled: Infusion Pumps
Reason of the recall: Deviations from the specified cleaning methods may impair infusion pump
FDA Recall date: October 29, 2020
Recall details: Baxter International Inc. announced today it has issued an Urgent Device Correction… See more

#medicaldevices #us

321

BD Alaris System Hardware - recalled due to Potential for four hardware situations that may result in the infusion pump not operating as expected, USA

3 years ago •source fda.gov • details

Recall notice

Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: BD Alaris System Hardware
Reason of the recall: Potential for four hardware situations that may result in the infusion pump not operating as expected
FDA Recall date: September 21, 2020
Recall details: Three Recalls Designated as… See more

#medicaldevices #recall #us

321

Alaris Infusion Pump - recalled due to Hardware issues may cause the infusion pump to not operate as expected, USA

3 years ago •source fda.gov • details

Recall notice

Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: Alaris Infusion Pump
Reason of the recall: Hardware issues may cause the infusion pump to not operate as expected
FDA Recall date: September 01, 2020
Recall details: Majority of June 30 Recall Designated as Class I… See more

#medicaldevices #us

321

Endologix® Inc. Ovation iX Stent Graft system - recalled due to material weakness, United States

3 years ago •source fda.gov • details

Recall notice

Company name: Endologix® Inc.
Brand name: Ovation
Product recalled: Ovation iX system
Reason of the recall: A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer.
FDA Recall date: July 08, 2020
Recall details: Company Announcement Endologix® Inc. (Nasdaq: ELGX)… See more

#medicaldevices #us

321

Infusion System Administration Set (infusion set) - recalled due to Use of the pump system potentially could cause over-infusion or under-infusion of therapy, USA

3 years ago •source fda.gov • details

Recall notice

Company name: CME America
Brand name: BodyGuard
Product recalled: Infusion System Administration Set (infusion set)
Reason of the recall: Use of the pump system potentially could cause over-infusion or under-infusion of therapy
FDA Recall date: July 08, 2020
Recall details: PRNewswire/ - CME America, a wholly owned… See more

#medicaldevices #us

Infusion System Administration Set (infusion set) - recalled due to Use of the pump system potentially could cause over-infusion or under-infusion of therapy photo #1
321

Chengdu Ai Qin Colored contact lenses - recalled due to being distributed without FDA clearance, USA

4 years ago •source fda.gov • details

Recall notice

Company name: Chengdu Ai Qin E-commerce Co., Ltd
Brand name: TTDeye
Product recalled: Colored contact lenses
Reason of the recall: Distributed without FDA clearance may pose health risk
FDA Recall date: June 24, 2020
Recall details: On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated… See more

#medicaldevices #us

Chengdu Ai Qin Colored contact lenses - recalled due to being distributed without FDA clearance photo #1
321

Allergan Aesthetics Breast Implants - recalled due to Increased risk of BIA-ALCL, USA

4 years ago •source fda.gov • details

Recall notice

Company name: Allergan Aesthetics
Brand name: BIOCELL
Product recalled: Breast Implants
Reason of the recall: Increased risk of BIA-ALCL
FDA Recall date: June 01, 2020
Recall details: Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tracking and further identify… See more

#medicaldevices #us

321

Infusion pumps and sets - recalled due to pumps may not deliver fluid at the accuracy specified in the instructions, USA

4 years ago •source fda.gov • details

Recall notice

Company name: CME America
Brand name: CMEAmerica BodyGuard
Product recalled: Infusion pumps and infusion sets
Reason of the recall: pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids
FDA Recall date: April 29, 2020
Recall details:… See more

#medicaldevices #us #evolve

Infusion pumps and sets - recalled due to pumps may not deliver fluid at the accuracy specified in the instructions photo #1
321

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