Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 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
Check against the official notice below — it lists the full affected range.
Penumbra Inc. is recalling the Penumbra JET 7MAX KIT (catalog number J7XKIT132), a medical device used in vascular procedures. The catheter in this kit may develop damage to its distal tip during use, which when combined with pressurized contrast injection, could cause blood vessel damage and result in serious patient injury or death. A total of 15 catheters have been distributed worldwide, including throughout the United States and multiple international locations.
The affected products have lot numbers ranging from C21487 through C21772 and F97946 through F98497, and can be identified by the UDI code 00815948021273. The recall record does not specify what actions affected consumers should take in response to this recall.
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: 15 catheters Lot/code info: Product Name: JET 7MAX (Penumbra JET 7 Xtra Flex + MAX Delivery Device) Catalog Number: J7XKIT132 UDI Code: 00815948021273 Lot Number Range: C21487 thru C21772 F97946 thru F98497
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.