Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT 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
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 5MAXJET7KIT) due to a defect that may cause the catheter's distal tip to become damaged during use. When the damaged tip is combined with pressurized contrast injection, it may result in vessel damage and serious patient injury or death.
The recall affects approximately 27,499 catheters distributed worldwide, including throughout the United States and in multiple countries such as Canada, Japan, Korea, and others. The affected products have lot numbers ranging from C15441 through C19176 and F88882 through F100278. The source document does not specify a remedy or instructions for what affected consumers should do.
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: 27,499 catheters Lot/code info: Product Name: Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing Catalog Number: 5MAXJET7KIT UDI Code: 00815948020962 Lot Number Range: C15441 thru C19176 F88882 thru F100278
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.