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DXQClass 2

Blood Pressure Cuff

FDA adverse event reports and recall history for blood pressure cuff (product code DXQ), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
470
Deaths
2
Injuries
132
Malfunctions
275

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2025-12-01Open, ClassifiedProcess control

    Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.

    Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.

  • 2025-04-15Open, ClassifiedDevice Design

    Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8) 84MTVEX-4; 9) 84MTVX2-4; 10) 84MTVX2-6; 11) 84MTVX2-B; 12) 84MTVX2-US; 13) 84MTVXC-4; 14) 84MTVXC-B; 15) 84MTVXP-2; 16) 84MTVXP-4; 17) 84MTVXP-B; 18) 84MTVXX-2; 19) 84MXVEC-4; 20) 84MXVEC-B; 21) 84MXVEP-4; 22) 84MXVEP-B; 23) 84NTVE2-6; 24) 84NTVE2-B; 25) 84NTVE2-US; 26) 84NTVEC-B; 27) 84NTVX2-6; 28) 84NTVX2-B; 29) 84NTVX2-US; 30) 84NTVXC-4; 31) 84NTVXC-B; 32) 84NTVXP-B; 33) 84NXVEC-4; 34) 84NXVEC-6; 35) 84NXVEC-B; 36) 84XTVXC-2; 37) 84XTVXC-B; 38) 85MTVE3-2; 39) 85MTVE3-4; 40) 85MTVE3-B; 41) 85MTVE3-US; 42) 85MTVEC-4; 43) 85MTVEC-B; 44) 85MTVEP-2; 45) 85MTVEP-B; 46) 85MTVX3-4; 47) 85MTVX3-B; 48) 85MTVX3-US; 49) 85MTVXC-6; 50) 85MTVXC-B; 51) 85MTVXX-6; 52) 85MXVEC-2; 53) 85MXVEC-4; 54) 85MXVEC-B; 55) 85MXVEP-4; 56) 85NTVE3-4; 57) 85NTVE3-6; 58) 85NTVE3-B; 59) 85NTVE3-US; 60) 85NTVEC-B; 61) 85NTVEP-2; 62) 85NTVEP-6; 63) 85NTVEP-B; 64) 85NTVX3-6; 65) 85NTVX3-B; 66) 85NTVX3-US; 67) 85NTVXC-B; 68) 85NTVXP-2; 69) 85NTVXP-B; 70) 85NXVEC-4; 71) 85NXVEC-B; 72) 85NXVEP-6.

    Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

  • 2025-04-15Open, ClassifiedDevice Design

    Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B; 5) ) Product Code/Part # 67NCTP-B; 6) ) Product Code/Part # 67NCTP-B-ECG3A; 7) ) Product Code/Part # 67NCTX-B; 8) ) Product Code/Part # 67NXEX-B; 9) ) Product Code/Part # 67NXTP-B; 10) ) Product Code/Part # 67NXTP-B-ECG3A; 11) ) Product Code/Part # 67NXTX-B; 12) ) Product Code/Part # 67NXXX-B; 13) ) Product Code/Part # 68MCTP-B; 14) ) Product Code/Part # 68MCTP-B-ECG3A; 15) ) Product Code/Part # 68MCTX-B; 16) ) Product Code/Part # 68MCXX-B; 17) ) Product Code/Part # 68MXDX-B; 18) ) Product Code/Part # 68MXEP-B; 19) ) Product Code/Part # 68MXEX-B; 20) ) Product Code/Part # 68MXTP-B; 21) ) Product Code/Part # 68MXTP-B-ECG3A; 22) ) Product Code/Part # 68MXTX-B; 23) ) Product Code/Part # 68MXTX-BR; 24) ) Product Code/Part # 68NCEP-B; 25) ) Product Code/Part # 68NCTP-B; 26) ) Product Code/Part # 68NCTP-B-ECG3A; 27) ) Product Code/Part # 68NCTX-B; 28) ) Product Code/Part # 68NCXP-B; 29) ) Product Code/Part # 68NXEP-B; 30) ) Product Code/Part # 68NXEX-B; 31) ) Product Code/Part # 68NXTP-B; 32) ) Product Code/Part # 68NXTP-B-ECG3A; 33) ) Product Code/Part # 68NXTX-B; 34) ) Product Code/Part # 68NXTX-BR; 35) ) Product Code/Part # 68NXXX-B; 36) ) Product Code/Part # 67MCTP-B; 37) ) Product Code/Part # 67MCTP-B-ECG3A; 38) ) Product Code/Part # 67MCTX-B; 39) ) Product Code/Part # 67MXEX-B; 40) ) Product Code/Part # 67MXTP-B; 41) ) Product Code/Part # 68MXXX-B.

    Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

  • 2025-04-15Open, ClassifiedDevice Design

    Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2MPX; 4) 77791-2MPX-HS; 5) 77791-2MPXL; 6) 77796-2MPX; 7) 77796-2MPXL.

    Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

  • 2025-04-15Open, ClassifiedDevice Design

    Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST; 2) WELCH ALLYN Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 407637; 3) WELCH ALLYN 767 Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 7670-10.

    Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

  • 2025-04-15Open, ClassifiedDevice Design

    Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.

    Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

  • 2024-06-06Open, ClassifiedUnder Investigation by firm

    GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 4. ONE-A1-1B-L, ONE-CUF, ADULT LONG, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 5. ONEA2-2A, ONE-CUF, ADULT, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 6. ONE-A2-2A-L, ONE-CUF, ADULT LONG, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 7. ONE-A3-1B, ONE-CUF, LARGE ADULT, 1 TB BAYONET, 31 - 40 CM, 20/BOX; 8. ONE-A3-2A, ONE-CUF, LARGE ADULT, DINACLICK 80369-5, 31 - 40 CM, 20/BOX; 9. ONE-P1-1B, ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM, 20/BOX; 10. ONE-P1-2A, ONE-CUF, INFANT, DINACLICK 80369-5, 08 - 13 CM, , 20/BOX; 11. ONE-P2-1B, ONE-CUF, CHILD, 1 TB BAYONET, 12 - 19 CM, 20/BOX; and 12. ONE-P2-2A, ONE-CUF, CHILD, DINACLICK 80369-5, 12 - 19 CM, 20/BOX.

    Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.

  • 2011-06-22TerminatedDevice Design

    Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus Road, Totowa, NJ 07512 Made in Mexico. The cuff is used to determine a subject's blood pressure.

    BP cuffs may not properly inflate due to a leak

  • 2006-09-09TerminatedOther

    CORDIS SV-5 Steerable Guidewire, 180 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company, ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA, Catalog # 503558.

    Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.

  • 2006-09-09TerminatedOther

    CORDIS-SV-5 Steerable Guidewire, 300 cm.,5 Steerable Guidewires,Cordis a Johnson Johnson Company ,ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA., Catalog # 503558X

    Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.

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