The FDA Announces the Recall Zoom 71 Reperfusion Catheters Due to Nine Reports of Serious Injury
According to a news article published on cardiovascularbusiness.com, the U.S. Food and Drug Administration reported that Imperative Care is recalling several batches of its Zoom 71 Reperfusion Catheters. The Zoom 71 Reperfusion Catheters are used in surgical procedures to extract blood clots in stroke patients. The recall was initiated after it was discovered that there is an increased risk of breakage during use. According to the FDA’s warning, if the catheter tip fractures, the pieces of the catheter could be left inside the patient’s bloodstream, leading to life-threatening adverse events, including strokes, blood vessel blockage, and death.
According to the FDA, the recall has been categorized as a Class I recall. Class I recalls are the most serious type of recall and may cause grave injuries or fatalities. So far, there have been nine serious injuries reported. Fortunately, there have not been any fatalities linked to the recalled catheters.
The Imperative Care Zoom 71 Reperfusion Catheter recall includes approximately 3,100 units that were sold from September 2020 until August 2021. Imperative Care first warned its purchasers in August, and they urge customers to “remove and quarantine all unused affected products.” The recalled catheters should be returned to Imperative Care, and the manufacturer promised to assist customers in finding a proper replacement.
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