There have been 48 medical device recalls issued in 2019, according to FDA, and the agency reported on four of those recalls just in the past week.
On Monday, MD+DI reported that Medtronic has recalled its SynchroMed II implantable drug infusion pump after receiving reports of early motor stall due to the potential presence of foreign particles inside the pump motor assembly. Since then, FDA has posted three more device recall notices, including one from Cook Medical, one from GE Healthcare, and one from Smiths Medical.
The most serious of these recent recalls is GE's recall of several infant incubators after receiving six reports of infant falls with injuries such as skull fractures, hematoma, and edema. No deaths have been reported. The recalled devices include: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestations. The company said the bedside panels can be upright and look closed but not be securely latched. The portholes can also look closed when not securely latched. If a canopy cover is used, it can hold the bedside panel or porthole door closed without being securely latched. If an infant comes in contact with a bedside panel or porthole that is unlatched, the panel or porthole can disengage and fall open, no longer protecting the infant from falling.
GE sent a letter to customers stating that users can continue to use their Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation systems by following specific instructions, which can be found here.
Cook has recalled its CrossCath Support Catheters due to a manufacturing error that may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014” wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018” wire guides). Marker bands that are too loose can dislodge from their original position and marker bands that are too tight can cause buckling.
FDA noted that use of the affected product can lead to increased procedure time to obtain a replacement, or due to difficult advancement of the catheter through a lesion, or because of additional intervention to remove a catheter that becomes stuck within a lesion, or additional intervention to remove separated marker bands. If the separated marker band cannot be retrieved it can cause permanent impairment like loss of limb; or the fragment can obstruct blood flow (embolize), resulting in life-threatening harm such as stroke, or death. Information about returning affected product to Cook can be found here.
Smiths Medical is recalling its Medfusion 4000 syringe pump because of a software issue in the most recently updated firmware of the device (version 1.7.0) that can potentially cause the low battery alarms to stop working. If the battery alarms do not work, the healthcare provider using the pump will not receive audible or visual notification that the battery is shutting down, which in turn may lead to an interruption of therapy. The company has received 74 complaints related to the software update but no injuries or deaths have been reported. Information on what to do with affected devices can be found here.
It's unclear exactly why there have been so many more medical device recalls in 2019 than in previous years, but one explanation is the fact that medical devices are increasingly reliant on software. Earlier this year Stericycle Expert Solutions reported that software issues are the top cause of medical device recalls.
"As we become increasingly reliant on AI and data collection, software becomes an even bigger vulnerability for patients, physicians, and wrongdoers," said Chris Harvey, director of recall solutions at Stericycle. "If the software that is used to operate a device is inadequate, how can we be sure that it is protected from cybersecurity vulnerabilities? Add to that the fact that companies have only recently been laser-focused on mitigating cyber threats associated with medical devices. It's a recipe for disaster."
Medtronic, Zimmer Biomet, Brainlab, Hamilton Medical, Fresenius Kabi, and Smiths Medical have all had to recall devices this year due to a software-related issue.