PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only.
Check against the official notice below — it lists the full affected range.
Biosense Webster has recalled the PENTARAY NAV eco High-Density Mapping Catheter, a medical device used to create maps of the heart's electrical activity during cardiac procedures. The recalled catheters can become entrapped in the heart's valvular structures while physicians are attempting to create these electroanatomic maps. Approximately 435,590 units have been distributed worldwide, including throughout the United States and in countries across Europe, Asia-Pacific, Latin America, and Canada.
The recall affects multiple product codes (D-1282-07, D-1282-08, D-1282-10, and D-1282-11) and numerous lot numbers. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Reason for recall: Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI IL, VA,, NE, OK, NJ, CT, KS, HI, CO, ND, RI, ID, MS, VT, DC and WV. The countries of (EMEA, APAC, LATAM, US, Canada) including: NZ,BE,DE,PL,SI,TR,HU,CO,KR,CL,PE,AU,BR,CA,CN,HK,ID Quantity: 435590 units Lot/code info: PENTARAY NAV eco High-Density Mapping Catheter: All Lots of the following product codes: D-1282-07, D-1282-08, D-1282-10 and D-1282-11 Product Code Product Description GTIN Number D-1282-07-S PENTARAY¿ NAV ECO 7FR, F, 4-4-4 10846835012217 Lot Number 30001176L 30003606L 30003607L 30001016L 30001251L 17625708L 30005207L 30005537L 30005089L 30005206L 30166349L 30166345L 30166346L 30166347L 30166348L 30166351L 17393341L 17630191L 17630192L 17630193L 17393342L 17393343L 17395423L 17630194L 17395888L 17397254L 17393340L 30338080L 30338081L 30009837L 30166350L 30338079L 17633498L 17633500L 30009839L 30009842L 30009843L 30009844L 30345912L 17633499L 30009838L 30009841L 30011828L 30011829L 30011830L 30011831L 30345911L 30345913L 17403221L 17404168L 17404171L 30173420L D-1282-08-S PENTARAY¿ NAV ECO 7FR, F, 2-6-2 10846835012224 Lot Number 17626989L 17626993L 17626995L 17626998L 17626991L 17626992L 17626999L 17627001L 17627002L 17627004L 30155766L 30155767L 30155769L 30155773L 30155778L 30161076L 30161087L 30161091L 30161095L 30161096L 30163666L 30163668L 30163674L 30164145L 30164147L 17388298L 17388451L 17388452L 17626996L 17626997L 17627000L 17627094L 17627096L 17627097L 17627098L 17627099L 17627101L 17627102L 17627103L 17627104L 17627105L 17627106L 17627107L 30001259L 30001261L 30003199L 30003200L 30003202L 30003204L 30003208L 30003209L 30003210L 30003211L 30003212L 30003214L 30003216L 30003217L 30155469L 30155765L 30155768L 30155770L 30155771L 30155772L 30155774L 30155775L 30155776L
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.