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The 10 Most Serious Medtech Recalls of Early 2016
April 14, 2016
7 Min Read
FDA in recent months has announced Class I recalls covering hundreds of thousands of medical devices.
From crack-prone catheters to high-tech trouble, here's a rundown of the most serious and/or widespread recalls:
Dexcom won FDA approval last year for its Dexcom G5 mobile continuous glucose monitoring (CGM) system, which sends glucose data directly to a smartphone. (Image courtesy of Dexcom)
1. A Massive Glucose Monitor Recall
Dexcom announced a massive continuous glucose monitor recall, involving more than 260,000 devices with alarms that may fail to sound. Rather than asking customers to return the devices, the San Diego company sent patients a letter February 23 listing instructions on how to test the receiver's audio alert. The company said that customers had complained that the speakers failed to provide audible alerts and alarms "in some or all circumstances," but did not explain what went wrong.
The recall covers the company's G4 Platinum receivers and the newest addition to the line--the G5 Mobile receiver, which FDA approved in August. The devices were manufactured between July 29, 2011 and March 10, 2016.
2. Sheath Separation in a Cardio Catheter Recall
One person died and six more suffered serious injuries due to a malfunctioning Intra-Aortic Balloon Catheter Kit and Percutaneous Insertion Kit made by Arrow International. A division of Teleflex Inc., Arrow (Reading, PA), recalled 47,140 of the devices worldwide Feb. 11.
The sheath body may separate from its hub during insertion, causing significant bleeding and interrupting the balloon's ability to increase blood flow.
3. A Pioneering Cardio Device That Needed Better Instructions
Abbott Vascular received nine reports of its MitraClip delivery system failing to detach from the clip, which resulted in the death of one patient and open-heart surgery to extract the device. The problem can also cause its mandrel component to fracture.
Rather than have providers return the clips, Abbott provided updated instructions and training for clinicians. The company maintains that the device, touted as the world's first percutaneous mitral valve repair system, is safe if clinicians follow the instructions.
Abbott, which issued a field safety notice, concluded that the delivery system's arm positioner was in the wrong position and, therefore, did not return to the neutral position during use, thus preventing the clip from disengaging.
There were 3534 devices on the market--including 1288 in the United States. Intended to treat mitral regurgitation, the MitraClip is indicated for use in patients for whom mitral valve surgery is contraindicated.
4. Aspiration Catheters with Potential Shaft Breakage
Boston Scientific recalled more than 21,000 of its Fetch 2 aspiration catheters on March 22 due to complaints of shaft breakage. The thrombectomy catheters are used during procedures to remove small blood clots from coronary arteries. Boston Sci acquired the product line from Bayer Medical Care Inc. The catheters were manufactured between June 11, 2014 and February 19, 2016.
All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications, according to the company. Device fragments could have obstructed blood flow or needed surgical removal.
Boston Sci is conducting an investigation to determine what caused the shafts to break, according to a company spokesperson.
5. An Assembly Problem Leading to a Catheter Recall
The technique used by a product assembler while adding the tip to 360 lots of Cook Medical catheters likely contributed to the tip splitting or separation, the company found. The problem led the Bloomington, IN-based company to issue its second major catheter recall since July 2015. The voluntary recall involved 360 lots of single lumen central venous catheters and pressure monitoring sets and trays, totaling 17,827 devices globally, according to a company press release distributed by FDA. The recall has been designated as Class I.
The devices were distributed between April 24, 2015 and October 23, 2015. Cook said it began notifying customers January 6.
In August 2015, FDA issued a Class I designation for a different recall of 95,167 Cook Medical Beacon tip angiographic catheters worldwide. The company had received 26 complaints of catheter-tip splitting and/or separation by the time the FDA issued its classification, and 14 medical device reports.
The Royal Flush Plus Beacon Tip High-Flow Catheter, as shown on Cook Medical's website
6. Nearly Half a Million Catheters Recalled
In February, Cook Medical expanded the Beacon tip angiographic catheter recall to include additional product lots. The recall now affects 408,011 total catheters distributed in the US, according to FDA.
The company had received 26 complaints of catheter-tip splitting and/or separation in the first round of the recall. Cook says there have been 14 medical device reports in which a tip split or separation occurred.
7. Scopes Linked to Superbug Outbreaks
In January, Olympus voluntarily recalled some 4400 of its TJF-Q180V duodenoscopes, implicated in superbug outbreaks in hospitals across the country.
The company told customers in a letter that it will replace the forceps elevator mechanism in the reusable scopes to make them easier to clean. At least 25 outbreaks sickened at least 250 patients in the United States and Europe between 2012 and 2015, according to a U.S. Senate report. Olympus waited nearly three years--until February 2015--to notify U.S. hospitals of problems with cleaning the scopes, the report says.
The scopes recall comes on top of $646 million that Olympus is paying to settle criminal and civil complaints that it paid kickbacks and bribes to health providers in both the United States and Latin America.
8. Laryngoscopes with Video Problems
Verathon Inc. recalled 6377 of its GlideScope titanium single-use video laryngoscopes because of a potential disruption in the video feed from the camera in the laryngoscope blades to the monitor. A disrupted or unstable video image may lead to delayed tracheal tube insertion, intubation failure, and other serious adverse health consequences, including low levels of oxygen in the blood (hypoxemia), end organ damage or death, according to FDA. Verathon issued the recall January 29.
Just weeks earlier, the company recalled GlideScope video laryngoscope blades that might separate, possibly causing patient injury or death. The company blamed the problem on "insufficient process controls and monitoring, potentially resulting in inadequate bonding of the silicone adhesive affixing the halves of the blade." The potential for blade separation may not be readily visible during routine inspection before or after intubation.
Dräger Evita V500 ventilator (left) and Babylog VN500 ventilator (right) (Images courtesy of FDA)
9. More Ventilator Woes for Dräger
Dräger Medical expanded its December 2015 recall of Evita V500 and Babylog VN500 ventilators to include the PS500 optional power supply units that were updated with new software as part of the December recall. The new software failed to correct the issue depleting the battery, according to FDA, and the Lübeck, Germany-based company will now replace all 2501 affected PS500 power supply units.
The ongoing PS500 power supply issue could cause the ventilator to shut down unexpectedly. If the ventilator shuts down, a patient may not receive necessary oxygen.
Dräger has had other models ofemergency transport ventilators recalled because an electrical issue may cause the devices to stop working if the control knobs are not regularly used.
10. A Packaging Problem at a Vendor
Vascular Solutions discovered that a vendor had failed to correctly package certain lots of its Guardian II hemostasis valves. The valves, used in catheterization procedures, were in the "open" position rather than following the final inspection and packaging protocol, according to Phil Nalbone, vice president of corporate development for the company. No injuries or deaths were reported.
Vascular Solutions (Maple Grove MN) recalled 26,550 valves, including 5283 sold in the U.S. The valves could leak air, leading to an air embolism, which could result in serious injury or death. The devices were manufactured from March 2015 to February 2016 and distributed from April 2015 to February 2016.
Learn more about cutting-edge medical devices at MD&M East/a>, June 14-15, 2016 in New York City.
Nancy Crotti is a contributor to Qmed and MPMN.
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