Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thro
Check against the official notice below — it lists the full affected range.
Penumbra Inc. is recalling the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (model 5MAXJET7) due to a hazard involving potential distal tip damage during use. When the catheter's distal tip becomes damaged and contrast is injected under pressure, this combination may cause vessel damage and result in patient injury or death. A total of 3,368 catheters have been distributed worldwide, including throughout the United States, Canada, and multiple other countries.
The affected catheters have catalog number 5MAXJET7 and UDI code 00815948020955, with lot numbers ranging from C15558 through C17703, F87621 through F101011, and H10851. The recall source does not specify what remedy affected consumers should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Reason for recall: The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. Distribution: Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Mal Quantity: 3,368 catheters Lot/code info: Product Name: Penumbra JET 7 Reperfusion Catheter Catalog Number: 5MAXJET7 UDI Code: 00815948020955 Lot Number Range: C15558 thru C17703 F87621 thru F101011 H10851
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.