On 12-May-2020, United States Food and Drug Administration (USFDA) released a recall news of medical devices (Python Embolectomy Catheters, Bard Embolectomy Catheters, and OTW Latis Cleaning Catheters) which are falling under class I category. This type of recall is most serious type of recall, as they may cause serious injuries or death.

The Python Embolectomy Catheters, Bard Embolectomy Catheters, and OTW Latis Cleaning Catheters are latex balloon catheters used for temporary blockage, closing of a blood vessel, or infusion of fluids.

On 24-Oct-2019, the manufacturer of these medical devices, “Applied Medical” had initiated the recall procedure for these products due to a risk of the catheter tip detaching during use. If the tip detaches, pieces of the catheter could break off into the patient’s body. If this occurs, there is also the potential for serious health consequences including additional surgical procedures to remove the tip, damage to the blood vessel, or death.

Since 2015. A total of 46 medicinal device incidents/complaints pertaining to this device issue were received by the manufacturer. The FDA had received three medical device reports (MDRs) and no reports of death or injury.

On November 08, 2019, Applied Medical sent an urgent medical device recall letter to the customers to check the inventory for the recalled product and to complete the recall Notification Confirmation Form to acknowledge the recall and to return the affected product and a copy of the Recall Notification Confirmation Form to Applied Medical.

These medical devices are manufactured during the period of 23-Jul-2015 to 08-Nov-2018 and distributed from 25-Aug-2015 to 01-Mar-2019. A total of 19,400 medical device products were recalled in this procedure with the below model numbers:

• Python Embolectomy Catheters: A4E01, A4E02, A4E03, A4E04, A4E05, A4E06, A4E08, A4E09
• Bard Embolectomy Catheters: CE0340DR, CE0380DR, CE0440DR, CE0480DR CE0540DR, CE0580DR, CE0680DR
• OTW Latis Cleaning Catheters: A4GW6

Voluntary Reporting:

Medical Device Class I Recall is a serious type of recall, as these class of products enter the market without prior robust clinical evaluation pertaining to safety and efficacy. The major channel of gaining the knowledge on product safety is through voluntary reporting of safety concerns from public to the regulatory bodies. Health care professionals and consumers are advised to report any medical device adverse incident reports or injuries to the FDA by online voluntary reporting facility through MedWatch online reporting. This would facilitate in accumulation of the more evident safety data which could expedite the regulatory actions by FDA.