Class I Recall for Applied Medical's Embolectomy Catheters

Megan Brooks

May 12, 2020

Applied Medical is recalling 19,400 of their Python embolectomy catheters, Bard embolectomy catheters, and OTW Latis cleaning catheters because the catheter tip could detach during use.

If this happens, pieces of the catheter could break off in the patient's body, potentially leading to serious harm including surgery to remove the tip, damage to the blood vessel, or death, the recall notice notes.

The US Food and Drug Administration (FDA) has identified this as a Class 1 recall, the most serious kind, because of the potential for serious injury or death.

Since 2015, there have been 46 complaints regarding this problem. The FDA has received three medical device reports but no reports of death or injury.

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

The recalled catheters were made between July 23, 2015, and November 8, 2018, and distributed between August 25, 2015, and March 1, 2019.

Recalled Product 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

Applied Medical has sent an "urgent" medical device recall letter to all affected customers advising them to check their inventory for the recalled product and complete a recall notification confirmation form to acknowledge the recall and indicate if any recalled catheters will be returned.

The recall confirmation notice should be returned to Applied Medical by email to recall60810330@appliedmedical.com or by fax to 949-713-8908.

For product return questions, customers may contact Jaclene Rios-Simpson, customer relations senior manager, at 949-713-8688 or jrios@appliedmedical.com.

Adverse reactions or quality problems related to this recall should be reported to the FDA's MedWatch program.

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