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Recalls

2 deaths reported in Medtronic HeartWare recall

March 1, 2021 By Nancy Crotti Leave a Comment

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, […]

Filed Under: Cardiac Implants, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: FDA, Medtronic

Hillrom has a serious overhead lift recall

February 22, 2021 By Danielle Kirsh Leave a Comment

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 […]

Filed Under: Food & Drug Administration (FDA), Recalls Tagged With: Hillrom

Cordis recalls some Precise Pro RX carotid stent systems

February 22, 2021 By Danielle Kirsh Leave a Comment

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 […]

Filed Under: Business/Financial News, Cardiovascular, Recalls Tagged With: Cardinal Health, Cordis

Boston Scientific has another serious recall on the same heart device

February 22, 2021 By Nancy Crotti Leave a Comment

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Featured, Food & Drug Administration (FDA), Implants, Recalls, Regulatory/Compliance Tagged With: Boston Scientific, FDA

The worst catheter-based device recalls of 2020

February 19, 2021 By Danielle Kirsh Leave a Comment

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 […]

Filed Under: Catheters, Featured, Food & Drug Administration (FDA), Recalls Tagged With: Abbott Vascular, Applied Medical, Arrow International, Boston Scientific, Cook Medical, Endologix, LeMaitre Vascular, Medtronic, Teleflex, Vascular Solutions

Medtronic issues voluntary recall of Valiant Navion thoracic stent graft system

February 17, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Featured, Recalls, Regulatory/Compliance, Stent Grafts, Stents, Structural Heart Tagged With: Medtronic

Silk Road Medical issues voluntary recall of Enroute transcarotid stent system

January 25, 2021 By Sean Whooley

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 […]

Filed Under: Blood Management, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Vascular Tagged With: Cardinal Health, Cordis Corp., Silk Road Medical Inc.

Cook Medical has a serious catheter recall

December 28, 2020 By Chris Newmarker

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). […]

Filed Under: Catheters, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: Cook Medical

Penumbra recalls some Jet 7 catheters after 14 deaths

December 15, 2020 By Danielle Kirsh

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. […]

Filed Under: Business/Financial News, Catheters, Featured, Recalls Tagged With: Penumbra

Olympus warns on endoscope infection risk

December 14, 2020 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Endoscopic, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: FDA, Olympus

Boston Scientific issues trio of warnings affecting thousands of ICDs

December 11, 2020 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Cardiac Implants, Featured, Recalls Tagged With: Boston Scientific

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