Events

Recall of Device Recall Invacare Pronto Air Personal Transporter (power wheelchair)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71613
  • Event Risk Class
    Class 2
  • Event Number
    Z-2358-2015
  • Event Initiated Date
    2015-02-02
  • Event Date Posted
    2015-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138406
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wheelchair, powered - Product Code ITI
  • Reason
    The batteries used in the invacare¿ pronto¿ air personal transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage.
  • Action
    Invacare sent an " Urgent Medical Device Recall " letter on April 6, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You should immediately contact your provider at the number below so a replacement batteries can be installed. If you have any questions concerning these instructions, please call Invacares recall support line at (877) 413-6008, Monday  Friday, 8 a.m.  5 p.m. EST, for assistance. Visit www.invacare.com/recall for more information about this recall.

Device

Device Recall Invacare Pronto Air Personal Transporter (power wheelchair)
  • Model / Serial
    Model #AIRPTMBDY18, Serial #s: 12JSZD60025, 12JSZD60026, 12JSZD60027, 12KSZD60001, 12KSZD60002, 12KSZD60004, 12KSZD60005, 12KSZD60006, 12KSZD60007, 12KSZD60008, 12KSZD60010, 12KSZD60013, 12KSZD60014, 12KSZD60015, 12KSZD60016, 12KSZD60017, 12KSZD60018, 12KSZD60019, 12KSZD60020, 12KSZD60021, 12KSZD60022, 12KSZD60023, 12KSZD60024, 12KSZD60026, 12KSZD60028, 12KSZD60029, 12KSZD60030, 12KSZD60031, 12KSZD60032, 12KSZD60033, 12KSZD60034, 12KSZD60035, 12KSZD60036, 12KSZD60037, 12KSZD60038, 12KSZD60039, 12KSZD60040, 12KSZD60041, 12KSZD60042, 12KSZD60043, 12KSZD60045, 12KSZD60046, 12KSZD60047, 12KSZD60048, 12KSZD60049, 12KSZD60050, 12KSZD60051, 12KSZD60052, 12KSZD60053, 12KSZD60054, 12KSZD60055, 12KSZD60056, 12KSZD60057, 12KSZD60058, 12KSZD60059, 12KSZD60060, 12KSZD60061, 12KSZD60063, 12KSZD60064, 12KSZD60065, 12KSZD60066, 12KSZD60067, 12KSZD60069, 12KSZD60070, 12KSZD60071, 12KSZD60072, 12KSZD60073, 12KSZD60075, 12KSZD60076, 12KSZD60077, 12KSZD60078, 12KSZD60079, 12KSZD60080, 12KSZD60081, 12KSZD60082, 12KSZD60083, 12KSZD60085, 12KSZD60086, 12KSZD60087, 12KSZD60088, 12KSZD60091, 12KSZD60092, 12KSZD60093, 12KSZD60094, 12KSZD60095, 12KSZD60096, 12KSZD60098, 12KSZD60099, 12KSZD60100, 12KSZD60101, 12KSZD60103, 12KSZD60105, 12KSZD60107, 12KSZD60108, 12KSZD60109, 12KSZD60110, 12KSZD60111, 12KSZD60112, 12KSZD60114, 12KSZD60115, 12KSZD60116, 12KSZD60117, 12KSZD60118, 12KSZD60120, 12KSZD60121, 12KSZD60122, 12KSZD60123, 12KSZD60124, 12KSZD60125, 12KSZD60126, 12KSZD60127, 12KSZD60128, 12KSZD60129, 12KSZD60130, 12KSZD60131, 12KSZD60134, 12KSZD60136, 12KSZD60137, 12KSZD60138, 12KSZD60139, 12KSZD60140, 12KSZD60141, 12KSZD60142, 12KSZD60143, 12KSZD60144, 12KSZD60145, 12KSZD60146, 12KSZD60147, 12KSZD60148, 12KSZD60149, 12KSZD60151, 12KSZD60152, 12KSZD60153, 12KSZD60154, 12KSZD60155, 12KSZD60156, 12KSZD60158, 12KSZD60159, 12KSZD60160, 12KSZD60162, 12KSZD60163, 12KSZD60164, 12KSZD60165, 12KSZD60166, 12KSZD60168, 12KSZD60169, 12KSZD60170, 12KSZD60171, 12KSZD60172, 12KSZD60173, 12KSZD60174, 12KSZD60176, 12KSZD60177, 12KSZD60178, 12KSZD60179, 12KSZD60180, 12KSZD60181, 12KSZD60182, 12KSZD60183, 12KSZD60186, 12KSZD60187, 12KSZD60188, 12KSZD60189, 12KSZD60190, 12KSZD60191, 12KSZD60192, 12KSZD60193, 12KSZD60194, 12KSZD60195, 12KSZD60197, 12KSZD60198, 12KSZD60199, 12KSZD60200, 12KSZD60201, 12KSZD60203, 12KSZD60204, 12KSZD60205, 12KSZD60206, 12KSZD60207, 12KSZD60209, 12KSZD60211, 12KSZD60212, 12KSZD60213, 12KSZD60214, 12KSZD60215, 12KSZD60216, 12KSZD60217, 12KSZD60219, 12KSZD60220, 12LSZD60001, 12LSZD60002, 12LSZD60003, 12LSZD60004, 12LSZD60006, 12LSZD60007, 12LSZD60008, 12LSZD60009, 12LSZD60011, 12LSZD60012, 12LSZD60014, 12LSZD60015, 12LSZD60017, 12LSZD60018, 12LSZD60020, 12LSZD60021, 12LSZD60024, 12LSZD60025, 12LSZD60026, 12LSZD60027, 12LSZD60028, 12LSZD60029, 12LSZD60030, 12LSZD60031, 12LSZD60032, 12LSZD60033, 12LSZD60034, 12LSZD60035, 12LSZD60036, 12LSZD60037, 12LSZD60040, 12LSZD60042, 12LSZD60043,12LSZD60044, 12LSZD60046, 12LSZD60047, 12LSZD60048, 12LSZD60049, 12LSZD60050, 12LSZD60051, 12LSZD60052, 12LSZD60053, 12LSZD60054,12LSZD60055, 12LSZD60056, 12LSZD60058, 12LSZD60059, 12LSZD60063, 12LSZD60064, 12LSZD60067, 12LSZD60068, 12LSZD60069, 12LSZD60070, 12LSZD60071, 12LSZD60072, 12LSZD60073, 12LSZD60074, 12LSZD60075, 12LSZD60076, 12LSZD60077, 12LSZD60078, 12LSZD60079, 12LSZD60080, 12LSZD60081, 12LSZD60083, 12LSZD60084, 12LSZD60085, 12LSZD60086, 12LSZD60088, 12LSZD60089, 12LSZD60091, 12LSZD60093, 12LSZD60094, 12LSZD60095, 12LSZD60096, 12LSZD60097, 12LSZD60098, 12LSZD60099, 12LSZD60100, 12LSZD60101, 12LSZD60102, 12LSZD60103, 12LSZD60104, 12LSZD60105, 12LSZD60107, 12LSZD60109, 12LSZD60110, 12LSZD60112, 12LSZD60113, 12LSZD60114, 12LSZD60115, 12LSZD60116, 12LSZD60117, 12LSZD60121, 12LSZD60122, 12LSZD60123, 12LSZD60124, 12LSZD60126, 12LSZD60127, 12LSZD60128, 12LSZD60129, 12LSZD60130, 12LSZD60131, 12LSZD60132, 12LSZD60134, 12LSZD60135, 12LSZD60136, 12LSZD60137, 12LSZD60139, 12LSZD60140, 12LSZD60141, 12LSZD60142, 12LSZD60144, 12LSZD60145, 12LSZD60146, 12LSZD60147, 12LSZD60149, 12LSZD60150, 12LSZD60151, 12LSZD60152, 12LSZD60155, 12LSZD60156, 12LSZD60158, 12LSZD60159, 12LSZD60160, 12LSZD60161, 12LSZD60162, 12LSZD60163, 12LSZD60164, 12LSZD60167, 12LSZD60168, 12LSZD60169, 12LSZD60170, 12LSZD60171, 12LSZD60172, 12LSZD60173, 12LSZD60174, 12LSZD60175, 12LSZD60176, 12LSZD60177, 12LSZD60178, 12LSZD60181, 12LSZD60182, 12LSZD60185, 12LSZD60187, 12LSZD60190, 12LSZD60192, 12LSZD60193, 12LSZD60194, 12LSZD60195, 12LSZD60197, 12LSZD60198, 12LSZD60199, 12LSZD60200, 12LSZD60201, 12LSZD60202, 12LSZD60203, 12LSZD60205, 12LSZD60206, 12LSZD60207, 12LSZD60208, 12LSZD60209, 12LSZD60210, 12LSZD60211, 12LSZD60212, 12LSZD60213, 12LSZD60214, 12LSZD60215, 12LSZD60216, 13CSZD60001, 13CSZD60002, 13CSZD60003, 13CSZD60004, 13CSZD60005, 13CSZD60006, 13CSZD60008, 13CSZD60009, 13CSZD60011, 13CSZD60013, 13CSZD60015, 13CSZD60016, 13CSZD60018, 13CSZD60019, 13CSZD60022, 13CSZD60023, 13CSZD60024, 13CSZD60025, 13CSZD60026, 13CSZD60028, 13CSZD60029, 13CSZD60031, 13CSZD60032, 13CSZD60034, 13CSZD60035, 13CSZD60036, 13CSZD60037, 13CSZD60039, 13CSZD60040, 13CSZD60041, 13CSZD60042, 13CSZD60044, 13CSZD60045, 13CSZD60046, 13CSZD60047, 13CSZD60048, 13CSZD60050, 13CSZD60051, 13CSZD60052, 13CSZD60054, 13CSZD60055, 13CSZD60056, 13CSZD60057, 13CSZD60058, 13CSZD60059, 13CSZD60066, 13CSZD60071, 13CSZD60072, 13CSZD60074, 13CSZD60075, 13CSZD60076, 13CSZD60077, 13CSZD60078, 13CSZD60079, 13CSZD60080, 13CSZD60082, 13CSZD60083, 13CSZD60084, 13CSZD60085, 13CSZD60087, 13CSZD60088, 13CSZD60091, 13CSZD60093, 13CSZD60095, 13CSZD60097, 13CSZD60098, 13CSZD60099, 13CSZD60100, 13CSZD60101, 13CSZD60102, 13CSZD60103, 13CSZD60104, 13CSZD60105, 13CSZD60107, 13CSZD60108, 13CSZD60110, 13CSZD60112, 13CSZD60113, 13CSZD60114, 13CSZD60115, 13CSZD60116, 13CSZD60117, 13CSZD60118, 13CSZD60119, 13CSZD60128, 13CSZD60130, 13CSZD60131, 13CSZD60133, 13CSZD60134, 13CSZD60135, 13CSZD60136, 13CSZD60138, 13CSZD60140, 13CSZD60141, 13CSZD60144, 13CSZD60146, 13CSZD60147, 13CSZD60148, 13CSZD60149, 13CSZD60150, 13CSZD60151, 13CSZD60153, 13CSZD60154, 13CSZD60155, 13CSZD60156, 13CSZD60157, 13CSZD60159, 13CSZD60163, 13CSZD60164, 13CSZD60166, 13CSZD60167, 13CSZD60168, 13CSZD60170, 13CSZD60171, 13CSZD60173, 13CSZD60175, 13CSZD60178, 13CSZD60180, 13CSZD60182, 13CSZD60183, 13CSZD60188, 13CSZD60189, 13CSZD60191, 13CSZD60193, 13CSZD60194, 13CSZD60198. 13CSZD60199, 13CSZD60200, 13CSZD60201, 13CSZD60203, 13CSZD60204, 13CSZD60205, 13CSZD60207, 13CSZD60208, 13CSZD60211, 13CSZD60213, 13CSZD60214, 13CSZD60215, 13CSZD60216, 13CSZD60219, 13CSZD60224, 13CSZD60225, 13CSZD60227, 13CSZD60229, 13DSZD60001, 13DSZD60002, 13DSZD60003, 13DSZD60004, 13DSZD60005, 13DSZD60007, 13DSZD60008, 13DSZD60010, 13DSZD60012, 13DSZD60013, 13DSZD60015, 13DSZD60016, 13DSZD60017, 13DSZD60019, 13DSZD60020, 13DSZD60021, 13DSZD60023, 13DSZD60024, 13DSZD60026, 13DSZD60027, 13DSZD60029, 13DSZD60030, 13DSZD60032, 13DSZD60033, 13DSZD60034, 13DSZD60035, 13DSZD60036, 13DSZD60037, 13DSZD60039, 13DSZD60040, 13DSZD60041, 13DSZD60042, 13DSZD60043, 13DSZD60044, 13DSZD60045, 13DSZD60046, 13DSZD60047, 13DSZD60055, 13DSZD60056, 13DSZD60057, 13DSZD60058, 13DSZD60059, 13DSZD60060, 13DSZD60061, 13DSZD60062, 13DSZD60065, 13DSZD60066, 13DSZD60067, 13DSZD60068, 13DSZD60069, 13DSZD60074, 13DSZD60075, 13DSZD60076, 13DSZD60077, 13DSZD60078, 13DSZD60079, 13DSZD60080, 13DSZD60081, 13DSZD60082, 13DSZD60084, 13DSZD60085, 13DSZD60086, 13DSZD60087, 13DSZD60088, 13DSZD60089, 13DSZD60091, 13DSZD60092, 13DSZD60095, 13DSZD60096, 13DSZD60097, 13DSZD60098, 13DSZD60099, 13DSZD60100, 13DSZD60101, 13DSZD60102, 13DSZD60103, 13DSZD60104, 13DSZD60105, 13DSZD60107, 13DSZD60108, 13DSZD60109, 13DSZD60110, 13ESZD60002, 13ESZD60003, 13ESZD60004, 13ESZD60005, 13ESZD60007, 13ESZD60008, 13ESZD60009, 13ESZD60010, 13ESZD60011l, 13ESZD60012, 13ESZD60014, 13ESZD60015, 13ESZD60016, 13ESZD60017, 13ESZD60018, 13ESZD60019, 13ESZD60020, 13ESZD60021, 13ESZD60022, 13ESZD60023, 13ESZD60024, 13ESZD60025, 13ESZD60027, 13ESZD60030, 13ESZD60031, 13ESZD60032, 13ESZD60033, 13ESZD60034, 13ESZD60035.13ESZD60036, 13ESZD60037, 13ESZD60038, 13ESZD60039, 13ESZD60040, 13ESZD60041, 13FSZD60001, 13FSZD60002, 13FSZD60003, 13FSZD60004, 13FSZD60005, 13FSZD60006, 13FSZD60009, 13FSZD60011, 13FSZD60012, 13FSZD60013, 13FSZD60014, 13FSZD60015, 13FSZD60016, 13FSZD60017, 13FSZD60018, 13FSZD60019, 13FSZD60020, 13FSZD60021, 13FSZD60022, 13FSZD60023, 13FSZD60024, 13FSZD60025, 13FSZD60027, 13FSZD60030, 13FSZD60031, 13FSZD60032, 13FSZD60033, 13FSZD60034, 13FSZD60035, 13FSZD60036, 13FSZD60037, 13FSZD60040, 13FSZD60041, 13FSZD60042, 13FSZD60043, 13FSZD60044, 13FSZD60045, 13FSZD60048, 13FSZD60049, 13FSZD60050, 13FSZD60051, 13FSZD60052, 13FSZD60053,13FSZD60054, 13FSZD60055, 13FSZD60056, 13FSZD60057, 13FSZD60058, 13FSZD60060, 13FSZD60061, 13FSZD60062, 13FSZD60063, 13FSZD60064, 13FSZD60067, 13FSZD60068, 13FSZD60069, 13FSZD60070, 13FSZD60071, 13FSZD60072, 13FSZD60075, 13FSZD60076, 13FSZD60078, 13FSZD60079, 13FSZD60080, 13FSZD60081, 13FSZD60082, 13FSZD60084, 13FSZD60085, 13FSZD60086, 13FSZD60088, 13FSZD60089, 13FSZD60094, 13FSZD60096, 13FSZD60097, 13FSZD60098, 13FSZD60100, 13FSZD60101, 13FSZD60102,13FSZD60103, 13FSZD60104, 13FSZD60106, 13FSZD60107, 13FSZD60111, 13FSZD60112, 13FSZD60114, 13FSZD60115, 13FSZD60118, 13FSZD60119, 13FSZD60120, 13FSZD60121, 13GSZD60001, 13GSZD60003, 13GSZD60004, 13GSZD60006, 13GSZD60007, 13GSZD60010, 13GSZD60011, 13GSZD60013, 13GSZD60014, 13GSZD60015, 13GSZD60016, 13GSZD60017, 13GSZD60018, 13GSZD60019, 13GSZD60022, 13GSZD60023, 13GSZD60024, 13GSZD60025, 13GSZD60026, 13GSZD60027, 13GSZD60030, 13GSZD60031, 13GSZD60032, 13GSZD60033, 13GSZD60036, 13GSZD60037, 13GSZD60038, 13GSZD60040, 13GSZD60042, 13GSZD60043, 13GSZD60045, 13GSZD60046, 13GSZD60048, 13HSZD60004, 13HSZD60005, 13HSZD60006, 13HSZD60007, 13HSZD60009, 13HSZD60010, 13HSZD60011, 13HSZD60013, 13HSZD60014, 13HSZD60015, 13HSZD60017, 13JSZD60002, 13JSZD60004, 13JSZD60010, 13JSZD60011, 13JSZD60013, 13JSZD60014, 13JSZD60015, 13JSZD60017, 13JSZD60018, 13JSZD60019, 13JSZD60020, 13JSZD60021, 13JSZD60023, 13JSZD60026, 13JSZD60034, 13JSZD60035, 13JSZD60037, 13JSZD60038, 13JSZD60039, 13JSZD60040, 13JSZD60041, 13JSZD60043, 13JSZD60045, 13JSZD60046, 13JSZD60047, 13JSZD60048, 13JSZD60049, 13JSZD60050, 13JSZD60051, 13JSZD60052, 13JSZD60053, 13JSZD60054, 13JSZD60055, 13JSZD60058, 13JSZD60060, 13JSZD60061, 13JSZD60063, 13JSZD60064, 13JSZD60065, 13JSZD60067, 13JSZD60069, 13JSZD60071, 13JSZD60074, 13JSZD60076, 13JSZD60077, 13JSZD60078, 13JSZD60079, 13JSZD60080, 14ESZD60005, 14ESZD60007, 14ESZD60008, 14ESZD60015, 14ESZD60016, 14ESZD60020, 14ESZD60021, 14ESZD60023, 14ESZD60024, 14ESZD60025, 14ESZD60038, 14ESZD60039, 14ESZD60044,14ESZD60057, 14ESZD60058, 14ESZD60061, 14ESZD60062, 14ESZD60063, 14ESZD60067, 14ESZD60069, 14ESZD60070, 14ESZD60071, 14ESZD60075, 14ESZD60076, 14ESZD60078, 14ESZD60080, 14ESZD60082, 14ESZD60087, 14ESZD60089, 14ESZD60090, 14ESZD60092, 14ESZD60093, 14ESZD60094, 14ESZD60096, 14ESZD60101, 14ESZD60103, 14ESZD60104, 14ESZD60105, 14ESZD60106, 14ESZD60108, 14ESZD60109, 14ESZD60111, 14ESZD60112, 14ESZD60113 & 14ESZD60114.  Model #AIRPTMBDY20, Serial #s: 12KSZD60009, 12KSZD60025, 12KSZD60084, 12KSZD60097, 12KSZD60104, 12KSZD60132, 12KSZD60135, 12KSZD60150, 12LSZD60016, 12LSZD60045, 12LSZD60061, 12LSZD60065, 12LSZD60082, 12LSZD60087, 12LSZD60111, 12LSZD60119, 12LSZD60143, 12LSZD60148, 12LSZD60153, 13CSZD60021, 13CSZD60049, 13CSZD60060, 13CSZD60106, 13CSZD60111, 13CSZD60123, 13CSZD60129, 13CSZD60142, 13CSZD60158, 13CSZD60192, 13CSZD60202, 13CSZD60210, 13DSZD60004, 13DSZD60006, 13DSZD60011, 13DSZD60022, 13DSZD60038, 13DSZD60050, 13DSZD60051, 13DSZD60052, 13DSZD60054, 13ESZD60001, 13ESZD60013, 13ESZD60026, 13FSZD60007, 13FSZD60026, 13FSZD60029, 13FSZD60077, 13FSZD60091, 13FSZD60092, 13FSZD60095, 13FSZD60099, 13GSZD60029, 13GSZD60044, 13HSZD60012, 13HSZD60016, 13JSZD60024, 13JSZD60033, 13JSZD60044, 13JSZD60056, 13JSZD60066, 14ESZD60017, 14ESZD60018, 14ESZD60027, 14ESZD60037, 14ESZD60040, 14ESZD60077, 14ESZD60081, 14ESZD60083 & 14ESZD60084.  Model #AIRPTBASE, Serial #s: 12KSZD60068, 12KSZD60119, 12LSZD60106, 12LSZD60166, 12LSZD60180, 13CSZD60092, 13DSZD60063, 13DSZD60064, 13DSZD60090, 13FSZD60008, 13FSZD60028, 13FSZD60046, 13FSZD60047, 13HSZD60001, 13JSZD60001, 13JSZD60068, 14ESZD60014, 14ESZD60022, 14ESZD60065, 14ESZD60068, 14ESZD60072, 14ESZD60074, 14ESZD60086, 14ESZD60088, 14ESZD60091, 14ESZD60097, 14ESZD60098, 14ESZD60102 & 14ESZD60107.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico, and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI., and to the countries of : AUSTRALIA, CANDA, FRANCE, NEW ZEALAND, SOUTH AFRICA, TRINIDAD AND TOBAGO
  • Product Description
    Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1 Invacare Way, Elyria OH 44035-4190
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA