BEUDAMED
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    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code DQX·September 19, 2013

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code DQX·April 19, 2011

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code DQX·March 30, 2010

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code DQX·June 22, 2012

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code DQX·March 8, 2010

    PROWLER MICROCATHETERS

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code KRA·March 8, 2010

    PORTEX

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTR·January 7, 2022

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CODMAN AND SHURTLEFF, INC·Product code NJE·July 21, 2016

    PORTEX SOFT SEAL CUFF TRACHEAL TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTR·October 1, 2022

    CATHETER EXIMO ATHERECTOMY

    FDA Adverse Event
    Malfunction ·EXIMO MEDICAL LTD.·Product code MCW·September 7, 2022

    ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 13, 2015

    TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or VA15B; Model Numbers: 10041461 (Acuson S2000) and 8263703 (V5M Transducer); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA Product is a medical device, a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. tis function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, MMode, Pulsed(PW) Doppler mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or harmonic imaging and 3d/4d imaging on a flat panel display. The device system is intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The device is a multi frequency, multi plane, phased sector array transducer. In the TEE (transesophageal echocardiography process where the device fails, the transducer is introduced into the esophagus of the patient to obtain images of the heart structure.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYO·April 7, 2009

    McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.

    FDA Recall
    Open, Classified ·Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom·Product code NAC·October 1, 2024

    MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.

    FDA Recall
    Open, Classified ·Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom·Product code NAC·October 1, 2024

    Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: pressure ulcers leg ulcers cavity wounds lacerations post-operative surgical wounds

    FDA Recall
    Open, Classified ·Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom·Product code NAC·October 1, 2024

    Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

    FDA Recall
    Open, Classified ·Product code OCW·April 15, 2026

    FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FGE·April 27, 2010

    FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FGE·April 27, 2010

    FLEXIMA Biliary Stent System, 11.5Fr-15cm, M00539390, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FGE·April 27, 2010

    FLEXIMA Biliary Stent System, 8.5Fr-15cm, M00539290, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FGE·April 27, 2010