Medtech Recall Round-Up: May 2024

FDA identified Tandem Diabetes Care’s recall of its version 2.7 of the Apple iOS t:connect mobile app used in conjunction with the t:slim X2 insulin pump with Control -IQ technology as Class I after receiving reports of 224 injuries connected to a software issue. The t:connect mobile apple is an Apple iOS-based software that works with the t:slim X2 insulin pump with Control-IQ technology as a method of viewing pump information and having limited control of the pump through compatible smartphone models, operating systems, and pump software versions.

Tandem specifically recalled version 2.7 of the t:connect mobile app — released Feb. 12, 2024, on iOS — by correction, not product removal, after reports that software issues may cause battery depletion of the pump. Noted software issues may cause the mobile app to crash and be automatically relaunched by the iOS operating system, which intermittently repeats and could lead to excessive Bluetooth communication. This communication may result in pump battery drain and lead to the pump shutting down sooner than typically expected. Unexpected shutdown would cause insulin delivery to stop, potentially leading to under delivery of insulin, and in turn, hyperglycemia, or diabetic ketoacidosis.

The company’s catheters are used to deliver microcatheters to the blood vessels in the brain or used as an aspiration catheter to remove blood clots in patients with ischemic stroke. Route 92 recalled specific lots of its products containing the Tenzing 7 Delivery Catheters after multiple instances of distal tip separation at the proximal marker band.

Using affected products containing a broken catheter tip may cause delays in surgery, and harm to the blood vessels. If the broken catheter tip is left in the body, it can lead to embolization of catheter fragments. There has been two injuries and one death reported to be associated with the issue.

FDA identified Philips Respironics Trilogy Evo continuous ventilator recall as Class I, over a month after the company initiated the voluntary correction in March. The ventilators affected by the recall — Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal — use a microprocessor-controlled blower to provide pressure support, pressure control, or volume control during breathing support.

Philips urged users to update the ventilators to the latest software version (1.05.06.00) due to a possible power malfunction that can cause the device to issue a “battery depleted” or “loss of power” alarm “while sufficient power is still available, resulting in a sudden loss of ventilation while the device alarms,” according to the FDA filing.

The loss of power alarm will stop therapy while operating on battery power alone. A battery depleted alarm, however, will continue therapy if plugged into a permanent power source like AC or DC power. The issue has been reported to happen when the ventilators have software other than version 1.05.06.00 installed, are operating in CPAP or PSV mode, and are not able to detect the respiratory effort of the patient for over 10 minutes.

Magadyne Medical Products announced the recall of all Megadyne Mega Soft Pediatric Patient Return Electrodes after reports of patient burn injuries in procedures in which the product was used. After the reports, a root cause investigation included testing which showed a combination of factors that, when together, may result in thermal injuries.

The electrode pad is designed for patients between 0.8 and 50 pounds — predominantly patients under the age of 12. As the combination of conditions that may result in injury are potentially more likely when the pad is used with infants and small children, the company decided to discontinue and recall the product.

Rad-G is a portable SET pulse oximetry device that also measures other vital parameters like respiration rate from the pleth, oxygen saturation, pulse rate, perfusion index, and pleth variability index.

The company recalled certain Rad-G devices after it was identified that the devices were powering off and on without pressing the power button, which can result in sudden change in the power state. If this were to occur, it could result in loss of patient monitoring and potentially result in delayed patient care. Masimo reported that it has received a total of 529 complaints related to the issue — an occurrence rate of 3%. Additionally, there have been two reports of death while patients were being monitored with the device, however, it has not yet been determined whether Rad-G powered off unexpectedly in these cases.

Abbott recalled the HeartMate 3 implant kit after complaint reviews identified blood leakage or air entering the seal interface between the LVAD inflow cannula and the apical cuff. The company noted that in all reports, the issue was observed during implantation of the device. Abbott reports 81 incidents, including 70 injuries and two deaths, related to this issue.

Hologic’s recall of its BioZorb Markers due to complications with the implanted device were identified as Class I by FDA after 71 injuries were reported as being related to BioZorb Markers. The recall is considered a correction, not a product removal.

The BioZorb marker is an implantable radiographic marker used to mark soft tissue, like breast tissue, for future medical procedures like radiation.

Hologic announced the recall after reports of complications and adverse events (AEs) connected to the implanted devices. Such complaints included pain, infection, rash, device migration, device erosion, seroma, discomfort, feeling the device in the breast, and the need for additional medical treatment to remove the device.

Hologic’s recall of its BioZorb Markers due to complications with the implanted device were identified as Class I by FDA after 71 injuries were reported as being related to BioZorb Markers. The recall is considered a correction, not a product removal.

The BioZorb marker is an implantable radiographic marker used to mark soft tissue, like breast tissue, for future medical procedures like radiation.

Hologic announced the recall after reports of complications and adverse events (AEs) connected to the implanted devices. Such complaints included pain, infection, rash, device migration, device erosion, seroma, discomfort, feeling the device in the breast, and the need for additional medical treatment to remove the device.