Medtronic (NYSE:MDT) is recalling its HeartWare HVAD pump implant kit because the device may fail to start, restart, or have a delay in restarting after the pump was stopped, the FDA announced today. These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of post-implant situations, […]
Recalls
Hillrom has a serious overhead lift recall
FDA has designated Hillrom’s recall of its Liko Multirall 200 overhead lift as Class I, its most serious level. Hillrom (NYSE:HRC) initiated the recall on Dec. 18, 2020. It involves 11,600 devices, which are used to move patients from room to room. The recalled devices have a risk of the Q-link strap locks not attaching to […]
Cordis recalls some Precise Pro RX carotid stent systems
Cordis, a Cardinal Health (NYSE:CAH) subsidiary, is recalling and removing certain lots of its Precise Pro RX carotid stent systems. The Precise Pro RX carotid stent system, which is used in patients with stenotic lesions of the carotid arteries, has the potential for the distal tip to become separated from the wire lumen on certain lots […]
Boston Scientific has another serious recall on the same heart device
The FDA has declared a second Class I recall within a month on a Boston Scientific implantable cardioverter defibrillator (ICD). This recall, which the company initiated with a trio of warnings in December, notified physicians that 3,350 Emblem S-ICD model A209 and A219 devices may exhibit electrical overstress while delivering high-voltage therapy. Variations in header assembly may […]
The worst catheter-based device recalls of 2020
The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019. The list of the most serious catheter-based device recalls […]
Medtronic issues voluntary recall of Valiant Navion thoracic stent graft system
Medtronic (NYSE:MDT) announced today that it issued a voluntary recall of unused Valiant Navion thoracic stent graft systems. Fridley, Minn.-based Medtronic’s global recall included informing physicians to immediately cease use of the device until further notice, according to a news release. The company initiated the recall in response to information it recently obtained from the Valiant […]
Silk Road Medical issues voluntary recall of Enroute transcarotid stent system
Silk Road Medical (NSDQ:SILK) announced today that it is voluntarily recalling additional lots of its Enroute transcarotid stent system. Enroute, which is manufactured by Cardinal Health (NYSE:CAH) subsidiary Cordis, has received a total of six product complaints between September 2020 and January 2021 involving an issue in which a tip detaches from the stent delivery system. Additionally, test […]
Cook Medical has a serious catheter recall
FDA has designated Cook Medical‘s recall of its Flexor Check-Flo introducers and Flexor tuohy-borst side-arm introducers as Class I, its most serious level. Cook Medical initiated the recall on Nov. 24. It involves 37,326 of the devices, which are used to deliver medical devices to blood vessels (though not vessels of the heart and brain). […]
Penumbra recalls some Jet 7 catheters after 14 deaths
Penumbra (NYSE:PEN) has issued an urgent voluntary recall of all configurations of its Jet 7 Reperfusion Catheters with Xtra Flex Technology because the catheter may become susceptible to distal tip damage during use. So far, Alameda, Calif.-based Penumbra has received 14 reports of death related to the problem out of the more than 30,000 distributed units. […]
Olympus warns on endoscope infection risk
Olympus (TYO:7733) is advising healthcare providers to inspect certain ultrasound endoscopes before using them due to the potential for patient infection. The global recall covers 8,522 devices distributed in the U.S., according to FDA records. In an urgent field safety notice, the company listed 23 models of endoscopes that might contain residual blood and foreign matter […]
Boston Scientific issues trio of warnings affecting thousands of ICDs
Boston Scientific (NYSE:BSX) is warning healthcare providers that patients implanted with certain of its older Emblem S-ICD cardioverter defibrillators may need early revision surgery due to premature battery depletion. The company expanded on an August 2019 advisory about 350 of its Emblem S-ICD models A209 and A219 to include approximately 38,350 active devices. The devices contain […]
