The announcement of recall and withdrawal of medicinal products and medical devices of class II and class III from market is considered usual. The recall scenario of a class I medical device due to serious injury to patient’s health is very rare and requires quite attention.
Class I medical devices are “considered safe” which does not require any prior clinical evaluation studies for safety and efficacy before entering the market. The devices can be commercialized by manufacturers through 510 (k) notification to FDA, which is an easy regulatory pathway for availing marketing authorization of a class I medical device.
The LeMaitre Over the Wire Embolectomy Catheter is a class I medical device which is used for surgical removal of emboli (blood clots that are lodged in a blood vessel) and thrombi (blood clots that form in the veins) during embolectomy and/or thrombectomy respectively. This product can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
On 10 Mar 2020, the firm LeMaitre Vascular, Inc. has initiated an “Urgent medical device recall” for their product “LeMaitre 5F Plus Over the Wire Embolectomy Catheter” (510(k) number: K022145), due to the risk of failure of this balloon catheter to deflate during use, which may ultimately lead to tip separation. If the balloon does not deflate, the tip of the catheter or the balloon could separate and obstruct or block the patient’s blood vessel while the surgeon attempts to remove the inflated balloon catheter.
LeMaitre Vascular, Inc identified an increased trend in reports of catheters failing to deflate during use. This could cause serious health consequences including additional surgical procedures to remove the tip or balloon pieces, damage to the blood vessel, thrombosis, or death. LeMaitre Vascular, Inc requested customers to immediately quarantine this recalled device, and to return all the recalled devices for the arrangement of replacement material.
During the period of 01-Jan-2018 to 23-Mar-2020, FDA received 26 Medical Device Reports, with one (1) injury and no deaths pertaining to this product. On 02-Apr 2020, FDA released a notification of this medical device recall which is considered as most serious type, as the product belongs to a class I medical device category.
Reference:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=180253