Stryker‘s (NYSE:SYK) Physio-Control business said today it won FDA premarket approval for the continued marketing and distribution of its Lifepak professional defibrillators in the US. The clearance includes its Lifepak 1000, refurbished Lifepak 20 defibrillator and monitor, Lifepak 20e defibrillator and monitor and the Lifepak 15 defibrillator and monitor, the Redmond, Wash.-based company said. “Physio-Control […]
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Physio-Control initiates select recall of Lifepak 20e defibs, monitors
Physio-Control is recalling select Lifepak 20e defibrillators and monitors over issues with power failures, according to a recall notice posted this month. The voluntary recall affects Lifepak 20e units built between September 2016 and June 2017, the company said. Physio-Control said it received reports from customers of power-related failures with the devices during initial deployment […]
Physio-Control recalls Cardinal Health-made pediatric AED electrodes
Physio-Control said today it launched a voluntary recall of pediatric defibrillation electrodes, made by Cardinal Health (NYSE:CAH), which are components in a number of the company’s Lifepak automated external defibrillators over issues with incorrect art that could lead to misuse. Redmond, Wash.-based Physio-Control said that artwork on the recalled defibrillation electrodes shows incorrect electrode placement for […]
Johnson & Johnson lands $260m Defense Dept. contract for orthopedic devices
UPDATED May 15, 2017, with comment from J&J. The U.S. Defense Dept. yesterday awarded a Johnson & Johnson (NYSE:JNJ) unit a contract for orthopedic products worth nearly $260.5 million. The 1-year contract with Piscataway, N.J.-based Johnson & Johnson Healthcare System includes 4 1-year options; the total maximum value of the agreement covers the life of the contract including […]
7 medtech stories we missed this week: April 21, 2017
From new and renewed partnerships to FDA approvals, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer […]
FDA labels Physio-Control’s Lifepak 1000 recall as Class I
The FDA today labeled a select recall of Physio-Control Lifepak 1000 defibrillators over electrical issues as Class I. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. The company’s Lifepak 1000 defibrillator is designed to […]
Battery issue prompts recall for Physio-Control’s LifePak 1000 AED
Physio-Control said last week that it is launching a voluntary field action for its LifePak 1000 defibrillator, after reports that the device can shut down unexpectedly during treatment. The Redmond, Washington-based company has received 34 reports describing instances when customers have attempted to use the LifePak device and it has shut down due to an […]
Stryker closes $1.3B Physio-Control deal
Stryker (NYSE:SYK) said today that it closed the $1.28 billion acquisition of automated external defibrillator maker Physio-Control from Bain Capital. Medtronic (NYSE:MDT) sold Physio-Control to Bain for $478 million in January 2012. The all-cash deal is expected to add slightly to Stryker’s adjusted earnings per share this year, the Kalamazoo, Mich.-based company said when the deal was announced in […]
Physio-Control recalls AED electrodes made by by 3rd party
Physio-Control issued an urgent field safety notice recalling certain lots of its Quik-Combo adult pacing/defibrillation/ECG electrodes and its Red-Pak preconnected system due to a potential for damage to the wire insulation. The company said that it hasn’t received any complains over the issue from customers, but that the use of products with the damaged insulation […]
Stryker prices $3.5B notes offering
Stryker (NYSE:SYK) said yesterday that it priced a senior notes offering worth $3.5 billion. The 4-tranche flotation consists of $750 million in 3-year, 2.0% fixed notes due in March 2019; $750 million in 5-year 2.625% fixed notes due in March 2021; $1.0 billion in 10-year 3.5% fixed notes due in March 2026; and another $1.0 billion in 30-year 4.625% fixed notes […]
Stryker to pay $1.3B for Physio-Control
Stryker (NYSE:SYK) said today that it agreed to pay $1.28 billion to Bain Capital for automated external defibrillator maker Physio-Control. Medtronic (NYSE:MDT) sold Physio-Control to Bain for $478 million in January 2012. The all-cash deal, slated to close at the beginning of the 2nd quarter, is expected to add slightly to Kalamazoo, Mich.-based Stryker’s adjusted earnings […]
