Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT 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 occlus
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 and Penumbra Hi-Flow Aspiration Tubing (catalog number 5MAXJET7L138KIT). The catheter may develop damage at its distal tip during use, which when combined with pressurized contrast injection could potentially cause vessel damage and result in patient injury or death.
The recalled products were assigned lot numbers F97123 through F98981; however, according to the recall record, no units from these lots were actually distributed. The product was intended for worldwide distribution including across the United States and multiple countries including Canada, Japan, Korea, Israel, and others. The source does not specify a remedy for affected consumers.
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: 0 catheters Lot/code info: Product Name: Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing Catalog Number: 5MAXJET7L138KIT UDI Code: 00815948021594 Lot Number Range: F97123 thru F98981 Note - none were distributed
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.