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Home » Topics » Regulatory » Product recall

Product recall
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Medtronic Minimed insulin pump

Medtronic recalls select Minimed insulin delivery systems

Oct. 4, 2024
By Holland Johnson
Medtronic plc reported a voluntary recall of certain insulin pumps after customers said a single drop, bump, or physical impact could shorten their battery life.
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FDA announces recall of Abbott Amplatzer sheath, correction for Abiomed Impella

July 28, 2023
By Mark McCarty
During the week of July 24, 2023, the FDA published several notifications of potentially elevated risks associated with medical devices, including a recall of a delivery sheath for the Amplatzer device by Abbott Laboratories. The agency also announced that Abiomed Inc. will provide a correction for the instructions for use (IFUs) for the Impella because of an issue seen when implanting the left ventricular assist device in patients with transcatheter aortic valve replacement (TAVR) devices.
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Burns associated with patient return electrode spark class I recall

July 11, 2023
By Mark McCarty
The U.S. FDA reported July 11 a class I recall for patient return electrodes used during electrosurgical procedures that may burn the patient with sufficient severity to induce a third-degree burn. More than 21,000 of the electrodes, made by Raritan, N.J.-based Ethicon Inc.’s Megadyne division, are subject to the recall, although the agency said the manufacturer is still conducting a root cause analysis of the issue.
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Abiomed’s fix for purge issues in some Impella 5.5 units falters

June 5, 2023
By Mark McCarty
The U.S. FDA reported a class I recall for a subset of the Impella 5.5 with Smartassist due to leakage of purge fluid from a pump sidearm that could ultimately lead to a loss of pump function. Abiomed Inc., the maker of the device, had previously introduced corrective measures intended to suppress the problem with leakage, but those corrections have not completely resolved the problem, leading to the withdrawal of 466 units that were distributed in the U.S. between Sept. 8, 2021, and March 6, 2023.
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Royal Philips headquarters

Philips says CPAP testing data still suggest no conspicuous health issues

Dec. 27, 2022
By Mark McCarty
Continuous positive airway pressure (CPAP) devices made by Philips Respironics Inc. are still presumed by the U.S. FDA and other regulators to present a health hazard to patients, but the company’s latest data seem to suggest otherwise. In a Dec. 21 statement, the Royal Philips subsidiary said that testing suggests no appreciable harm to health related to particulate matter emissions from the polyester-based polyurethane (PE-PUR) foam in these devices, and that there is no evidence of long-term harm associated with volatile organic compounds (VOCs), both of which are conclusions with which the FDA may not agree.
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FDA deems Teleflex/Arrow recall of catheter kits a class I event

Sensititre plates recalled
Dec. 20, 2022
By Mark McCarty
The FDA posted a recall announcement for two catheter kits made by Arrow International LLC, a subsidiary of Wayne, Pa.-based Teleflex Inc., due to problems with the connectors used in the kits. While no injuries or deaths have been reported, the problem could lead to embolism and/or delayed delivery of needed therapeutic fluids to patients, making this a class I recall due to the risk of injury and death.
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U.S. FDA headquarters

Medical device reports continue to climb after recall of Philips Respironics CPAPs, ventilators

Aug. 23, 2022
By Mark McCarty
The recall of CPAP, BiPAP and ventilator devices made by Philips Respironics Inc., of Murrysville, Pa., is now in its second year, but the rate of reported adverse events was exceedingly low prior to the onset of the June 2021 recall. Those numbers continued to climb in May, June and July of 2022, however, reaching 48,000 medical device reports and 44 deaths said to be associated with the recalled devices, a pace that would easily overwhelm the volume of reports seen in the 12 months ending April 30, 2022.
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GE Healthcare issues class I recall for ventilators due to battery issues

July 1, 2022
By Mark McCarty
GE Healthcare issued a class I recall for Carescape R860 ventilators that covers more than 4,000 units distributed in the U.S., which was necessitated by problems with the battery backup component. No injuries or deaths have been reported in connection with the problem.
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Product recall concept image

BD recalls intraosseous needle set kits, power drivers

June 24, 2022
By Mark McCarty
Becton, Dickinson & Co. (BD) recalled intraosseous needle set kits and power drivers. The action was triggered by difficulties in separating the stylet from the needle. The FDA also announced a class I recall of the Volara respiratory clearance system by Baxter Healthcare Corp., of Deerfield, Ill., because of issues with an in-line ventilator adapter.
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Abbott announces class I recall of Dragonfly Opstar catheter

May 31, 2022
By Mark McCarty
The FDA announced a class I recall of the Dragonfly Opstar imaging catheter by Abbott Vascular, of Santa Clara, Calif., due to the loosening of a band marker that may lead to separation from the catheter. The agency said two instances in which the marker has separated from the catheter have been reported, with another three incidents of loosening without separation.
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