BEUDAMED
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    Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code JXG·December 8, 2020

    REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code JXG·December 16, 2020

    Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY 25121-5 DELTA SML SNAP P-CATH 120, 25131-1 - DELTA 25131-1 INTL ONLY SHUNT SM 1.0, 25131-2 - SHUNT 25131-2 INTL ONLY DELTA SM 2.0, 25131-5 - SHUNT 25131-5 INTL ONLY DELTA SM 1.5, 25132-2 - SHUNT 25132-2 INTL ONLY DELTA REG.2.0, 25132-5 - SHUNT 25132-5 INTL ONLY DELTA REG 1.5, 27219-1 - VALVE 27219-1 NEONATE DELTA, 27219-2 - VALVE 27219-2 NEONATE DELTA, 27219-5 - VALVE 27219-5 DELTA NEONATE 1.5 IMP, 27554-1 - VALVE 27554-1 DELTA SM EXTRACTED PL 1.0, 27554-2 - VALVE 27554-2 DELTA SM EXTRACTED PL 2.0, 27554-5 - VALVE 27554-5 DELTA SM EXTRACTED PL 1.5, 42812 - VALVE 42812 DELTA SMALL LEVEL I, 42813 - VALVE 42813 DELTA SMALL LEVEL 1.5, 42814 - VALVE 42814 DELTA SMALL LEVEL II, 42822 - VALVE 42822 DELTA REG PRESS LEVEL I IMP, 42823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5, 42824 - VALVE 42824 DELTA REG PRESS LEVEL II IMP, 46812 - ASSY 46812 DELTA SHUNT SMALL PL 1, 46813 - ASSY 46813 DELTA SHUNT SM LEV 1.5, 46822 - ASSY 46822 DELTA SHUNT REG P/L 1, 46823 - ASSY 46823 DELTA SHUNT REG LEV 1.5, 46824 - ASSY 46824 DELTA SHUNT REG P/L 2, 46832 - SHUNT 46832 NEONATAL DELTA SNAP L 1, 46833 - SHUNT 46833 NEONATAL DELTA SNAP 1.5, 46834 - SHUNT 46834 NEONATAL DELTA SNAP L 2, 92822 - VALVE 92822 BIOGLIDE DELTA REG. 1.0, 92823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5,

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code JXG·January 11, 2021

    Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN 27702 EDMS 27702 EURO BECKER II GR PT LN 27761 BECKER 27761 STOP BCNDLESS PATLN 24 27767 BECKER 27767 NO STPCOCK ON PTLN 63 27779 EDMS 27779 BECKER BC NDLESS BOND CONN 27811 EDMS 27811 BECKER GRN PL VCATH 27931 EDMS 27931 BECKER GS TUBING SMARTSITES 46128 EDMS 46128 BECKER II BLUE PT LN 46129 EDMS 46129 EURO BECKER II BLUE PT LN The Becker External Drainage and Monitoring System (Becker EDMS) is a closed system for: 1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space. 2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code GWM·November 1, 2024

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code JXG·December 16, 2020

    Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PER 90CM SM LOW 22017 B-M - SHUNT 22017 B-M ASSY US PER 90CM SM MED 22017B-LL - SHUNT 22017B-LL ASSY US PER 90CM SM LL 23093 - VALVE 23093 CONT. REG. LOW-LOW 27102 - VALVE 27102 CONTOURED SML LOW LOW 27553 M - VALVE 27553 M CSF-FLOW CNTRL SM EXTR MP 27643M - SHUNT 27643M ASSY SM PCATH130CM MED 27683M - SHUNT 27683M RG SNP PCATH90 PLI STD OE 42312 - VALVE 42312 SM CONTOURED LOW PRES IMP 42314- VALVE 42314 SM CONTOURED MED PRESS IMP 42316 - VALVE 42316 SM CONTOURED HIGH PRESS 42322 - VALVE 42322 CONTOURED REG LOW PRESS IMP 42324 - VALVE 42324 CONTOURED REG MED PRESS IMP 42326 - VALVE 42326 CONT HIGH PRESS IMP 42410 - VALVE 42410 ULTRA SMALL LOW-LOW 42414 - VALVE 42414 ULTRA SMALL MEDIUM PRESS IMP 42532 - VALVE 42532 BURR HOLE 12MM LOW PRESS IMP 42534 - VALVE 42534 BURR HOLE 12MM MED PRESS IMP 42536 - VALVE 42536 BURR HOLE 12MM HI PRESS IMP 42542 - VALVE 42542 BURR HOLE 16 MM LOW IMP 42544 - VALVE 42544 BURR HOLE 16MM MED PRESS IMP 42546 - VALVE 42546 BURR HOLE 16MM HI PRESS IMP 46564 - SHUNT 46564 CSF SNAP ASSY US MEDIUM 46622 - SHUNT 46622 CSF ASSY SMALL LOW CONT C/P 46624 - SHUNT 46624 CSF ASSY SMALL MED CONT C/P 46626 - SHUNT 46626 CSF ASSY SMALL HIGH CONT C/P 46642 - SHUNT 46642 ASSY REG LOW C/P-90CM 46644 - SHUNT 46644 ASSY REG MED C/P-90CM 46646 - SHUNT 46646 ASSY REG HIGH C/P-90CM 9003 A - KIT 9003 A INTL ONLY SHUNT CONT SM LO 9003 B - KIT 9003 B INTL ONLY SHUNT CONT SM ME 9003 C - KIT 9003 C INTL ONLY SHUNT CONT SM HI 9003 D - KIT 9003 D SHUNT INTL ONLY CONT REG L 9003 E - KIT 9003 E SHUNT INTL ONLY CONT REG M 9003 F - KIT 9003 F SHUNT INTL ONLY CONT REG H 9040 A - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW 9040 B - KIT 9040 B SHUNT INTL ONLY BH 12MM MED 9040 C - KIT 9040 C SHUNT INTL ONLY BH 12MM HIGH 9040 D - KIT 9040 DSHUNT INTL ONLY BH 16MM LOW 9040 E - KIT 9040 E SHUNT INTL ONLY BH 16MM MED 9040 F - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW 92322 - VALVE 92322 CSF CONT REG LOW BIO 92324 - VALVE 92324 CSF CONT REG MED BIO

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code JXG·January 11, 2021

    Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code JXG·June 28, 2023

    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 27814 STRATA II ASSY SML, 27815 - SHUNT 27815 STRATA II ASSY REG, 27816 - SHUNT 27816 SNAP STRATA II SMALL, 27817 - SHUNT 27817 SNAP STRATA II REG, 27818 - SHUNT 27818 STRATA II SML BIO, 27819 - SHUNT 27819 STRATA II REG BIO, 27823 - SHUNT 27823 STRATA II ASSY SNP REG BIO, 27827 - VALVE 27827 STRATA II REG EXTRACTED, 27888 - SHNT 27888 STRATA II SNAP ASSY REG PCATH, 42335 - VALVE 42335 STRATA NSC BURR HOLE, 42355 - VALVE 42355 FP STRATA NSC SMALL, 42365 - VALVE 42365 FP STRATA NSC REGULAR, 42836 - VALVE 42836 STRATA II BURR HOLE, 42856 - VALVE 42856 FP-STRATA 2 SMALL, 42866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 44420 - SHUNT 44420 STRATA KIT NSC LP, 44421 - KIT 44421 STRATA NSC LP OPEN LUMBAR, 44430 - SHUNT 44430 STRATA KIT NSC LP ASSY, 44465 - VALVE 44465 STRATA NSC LP, 46636 - SHUNT 46636 STRATA NSC BURR, 46655 - ASSY 46655 FP SHUNT STRATA NSC SMALL, 46665 - ASSY 46665 FP SHUNT STRATA NSC REG, 46837 - SHUNT 46837 STRATA II BURR HOLE, 46856 - ASSY 46856 FP-STRATA 2 SHUNT SML, 46866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 92355 - VALVE 92355 STRATA NSC SML BIOGLIDE, 92856 - VALVE 92856 FP STRATA 2 SML BG, 92866 - VALVE 92866 FP STRATA 2 REG BG,

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code JXG·January 11, 2021

    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code GXQ·June 13, 2023

    Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code JXG·December 8, 2020

    Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS 27795 EXACTA 100ML CATH 27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL 46700 SYSTEM 46700 EXACTA DISP. DRAINAGE 46705 SYSTEM 46705 EXACTA DRAINAGE 100ML The Exacta external drainage and monitoring system (EDMS) is a system for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring intracranial pressure (ICP).

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code GWM·November 1, 2024

    REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code JXG·December 16, 2020

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code JXG·December 8, 2020