CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

Recall details

Manufacturer

St. Jude Medical

Distributor

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK, United Arab Emirates.

Lot

UDI/DI 05414734509237, Serial numbers: H24Y92, H24YB8, H24YJY, H24YSK, H24YY9, H24YZG, H24Z3B, H24Z8S, H24ZEE, H24ZF7, H24ZHH, H24ZMN, H24ZTV, H24ZVP, H24ZWL, K24YFW, K25YCE, K25YEY, K25YKN, K25Z4K, K26WLC, K26WN6, K26WT4, K26WVE, K26WY3, K26WZA, K26X2N, K26X48, K26X53, K26X6A, K26X7H, K26X84, K26X97, K26XEQ, K26XGS, K26XHP, K26XJV, K26XKW, K26XLB, K26XMG, K26XN9, K26XPX, K26XQU, K26XVH, K26XWA, K26XY4, K27VK3, K27VNU, K27VP2, K27VQ9, K27VUV, K27VWP, K27W2W, K27W5B, K27W8C, K27W9F, K27WA4, K27WBD, K27WNH, K27WQL, K27X2Z, K27X4F, K27XGM, L23YVM, L23YXT, L23YYY, L23YZR, L23Z3J, L23ZAB, L23ZDL, L23ZEP, L23ZFW, L23ZHQ, L23ZN6, L23ZRJ, L23ZZA, L24262, L2428C, L2429F, L242A4, L242BD, L242CE, L242EY, L242JM, L24XVJ, L24Y4E, L24Y5D, L24Y64, L24Y8A, L24YA2, L24YBB, L24YKQ, L24YM6, L24YQJ, L24YRT, L24YSY, L24YXH, L24YYA, L24Z38, L24Z4M, L24Z6X, L24Z8R, L24ZE5, L24ZFC, L24ZJG, L24ZKB, L24ZMV, L24ZUM, L25X6W, L25XD7, L25XE4, L25XGE, L25XJH, L25XLX, L25XMU, L25XNM, L25XQG, L25XR9, L25XTP, L25XUL, L25XVV, L25XXK, L25XYQ, L25XZZ, L25Y3L, L25Y52, L25Y7G, L25YAD, L25YB4, L25YDJ, L25YFY, L25YGT, L25YHN, L25YRL, L25YSP, L25YT2, L25YU9, L25YVG, L25Z2C, L25Z4S, L25Z5Z, L26WBB, L26WCG, L26WDV, L26WFP, L26WGL, L26WL5, L26WM6, L26WNF, L26WPR, L26WRT, L26WSY, L26WV7, L26WXH, L26WYA, L26X2X, L26X3U, L26X4H, L26X5A, L26XA5, L26XL2, L26XM9, L26XSX, L26XW3, L26Y5X, L26Y8Y, L27VVV, L27VYQ, L27W7G, L27WMH, L27WZC, L27X55, L27X7F, L27X82, L27X99, L27XDM, L27XJT, L28UW6, L28V5L, L28V9Q, L28VCR, L28VE7, L28VMX, L28VS9, L28VUP, L28VWV, L28VXQ, L28VYK, L28VZS, L28W2L, L28W59, L28W95, L28WDR, L28WKU, L28WN3, L28WQW, L28WRP, L29UB6, L29UDQ, L29UFS, L29UHL, L29UJW, L29UMB, L29UN2, L29URN, L29USM, L29UX4, L29UY7, L29UZE, L29V3D, L29V4Y, L29V5T, L29V7R, L29V9X, L29VAL, L29VBV, L29VDB, L29VEG, L29VG2, L29VHF, L29VLK, L29VMQ, L29VNZ, L29VP7, L29VQ4, L29VRD, L29VXX, L2ATFV, L2ATJZ, L2ATLF, L2ATPT, L2ATQY, L2ATSJ, L2ATT7, L2ATZH, L2AU34, L2AU4R, L2AU8M, L2AUGB, L2AUH6, L2AULS, L2AUMZ, L2AUNQ, L2AUPE, L2AUUR, L2AUVY, L2AUWT, L2AUYM, L2AV2U, L2AV3X, L2AV4A, L2AV68, L2AV9D, L2AVA6, L2BSNP, L2BSR3, L2BSYJ, L2BSZT, L2BT3C, L2BT5S, L2BT9W, L2BTAM, L2BTF8, L2BTJ4, L2BTTS, L2BTUZ, L2BTZL, L2BU66, L2BU9B, L2BUCA, L2BUHT, L2BUKJ, L2BUL7, L2BUM4, L2CRUC, L2CRW6, L2CRXB, L2CS4Z, L2CS6K, L2CS8V, L2CS9W, L2CSBU, L2CSCX, L2CSDA, L2CSEH, L2CSF8, L2CSJ4, L2CSRC, L2CSWK, L2CSXW, L2CSYV, L2CT28, L2CT4N, L2CT9R, L2CTCQ, L2CTFF, L2CTMW, L2CTNP, L2CTR3, L2CTS8, L2DR8S, L2DRCY, L2DRF7, L2DRG4, L2DRHH, L2DRP9, L2DRRB, L2DRTV, L2DRXZ, L2DS8F, L2DSDY, L2DSET, L2DSSV, L2DSTG, L2EQCC, L2ERBL, L2ERJC, L2ERKF, L2ERLS, L2ERMZ, L2ERPE, L2ERQD, L2ERR4, L2ERTJ, L2ERUR, L2ERVY, L2ERWT, L2ERZU, L2ES2J, L2ES3R, L2ES44, L2ES7D, L2ES88, L2ESAG, L2FPMA, L2FPN3, L2FPPV, L2FPU2, L2FPWG, L2FPX5, L2FPY6, L2FQ29, L2FQ32, L2FQ9Q, L2FQAT, L2FQBJ, L2FQD4, L2FQE7, L2FQFE, L2FQGD, L2FQH8, L2FQR2, L2FQTL, L2FR5F, L2FR66, L2FR75, L2FR8G, L2FR9B, L2FRA8, L2FRCA, L2FRL7, L2FRM4, L2GNV5, L2GNW6, L2GNXB, L2GNYG, L2GP2T, L2GP3Y, L2GP5E, L2GP67, L2GP74, L2GP9A, L2GPA9, L2GPBG, L2GPDW, L2GPEV, L2GPFL, L2GPJQ, L2GPKK, L2GPL6, L2GPNC, L2GPPJ, L2GPQR, L2GPST, L2GPTE, L2GPV4, L2GPXA, L2GPZ8, L2GQ3D, L2GQ4Y, L2GQ5T, L2GQ6J, L2GQAL, L2GQEG, L2GQF9, L2GQG2, L2GQJ5, L2GQNZ, L2GQSE, L2GQTT, L2GQVR, L2JMFX, L2JMZB, L2JN6P, L2JN8Z, L2JNF4, L2JNHA, L2JNLN, L2JNQ9, L2JNXS, L2JNYZ, L2JNZQ, L2JP2A, L2JP3H, L2JPCS, L2JPDF, L2KLXT, L2KMA5, L2KMBC, L2KMCF, L2KMEZ, L2KMFQ, L2KMGK, L2KMKP, L2KMPN, L2KMQM, L2KMRU, L2KMSX, L2KMTA, L2KMUH, L2KMV8, L2KMW3, L2KMXE, L2KMYD, L2KMZ4, L2KN24, L2KN6Y, L2KN7T, L2KN8N, L2KN9M, L2KNAW, L2KND9, L2KNH5, L2KNKC, L2KNMS, M22ZEW, M22ZPR, M22ZRT, M2322A, M2327M, M232G6, M232K2, M232XT, M23YXV, M23YZP, M23Z96, M23ZC7, M23ZGT, M23ZQV, M23ZSP, M23ZT2, M24Y62, M24Y9F, M24YA4, M24YCE, M24YL3, M24YZ5, M24Z36, M24Z5Q, M24Z7S, M24ZFA, M24ZKD, M24ZLY, M26WDT, M26WEY, M26WHX, M26WM8, M26WPP, M26WTB, M26WV9, M26WZ5, M26X3S, M26X5C, M26X76, M26XGM, M26XHY, M26XJJ, M26XL4, M26XNE, M26XRS, M26XSZ, M26XUF, M26XV6, M26XW5, M26XZ2,

Risk classification

Class II

Area (FDA)

device

Country

United States