|
Product Description
|
Recall Class
|
Date Posted
|
Recalling Manufacturer
|
medtronic carelink smartsync device manager application software (d00u005) used by the following med |
2
|
11/24/2021
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
implantable cardiac resynchronization therapy pacemakers (crt-p) - product usage: used to treat arrh |
2
|
05/04/2021
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
crt-p quad models (crt-ps):
a. percepta crt-p mri: w1tr01, w1tr04, w4tr01, w4tr04
b. serena crt-p |
2
|
04/30/2021
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
carelink smartsync device manager (24970a). used to interrogate cardiac implantable electronic devi |
2
|
04/30/2021
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic carelink encore 29901 programmer. used to interrogate and program medtronic and vitatron |
2
|
03/19/2020
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic carelink 2090 programmer. used to interrogate and program medtronic and vitatron implanta |
2
|
03/19/2020
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
programmers & remote monitoring software apps:
2090 carelink programmer |
2
|
10/30/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
programmers & remote monitoring software apps:
29901 carelink encore programmer
|
2
|
10/30/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
programmers & remote monitoring software apps:
carelink smartsync device manager
|
2
|
10/30/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic micra mc1vr01, single chamber transcatheter pacing system, ref mc1vr01us (us only). cardi |
2
|
09/09/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic micra mc1vr01, ref mc1vr01 (ous only). cardiac pacemaker. |
2
|
09/09/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic power supply 26907, medtronic carelink encore(tm) 29901 programmer |
2
|
02/16/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic implantable pulse generator: sensia, dual chamber pacemaker (ddd):
(a) model number sed |
1
|
02/14/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
vitatron (implantable pulse generator):
(a) a-series, model numbers: a30a1, a60a1
(b) e-series, |
1
|
02/14/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic implantable pulse generator: versa, dual chamber rate responsive pacemaker (dddr), model |
1
|
02/14/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic implantable pulse generator: sphera dr mri surescan, dual chamber rate responsive pacemak |
1
|
02/14/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic implantable pulse generator: relia, dual chamber pacemaker (vdd):
(a) model number red0 |
1
|
02/14/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic implantable pulse generator: attesta l dr mri surescan, dual chamber rate responsive pace |
1
|
02/14/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic implantable pulse generator: adapta, dual chamber pacemaker (ddd):
(a) model number add |
1
|
02/14/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic carelink 29901 programmer for medtronic and vitaron devices |
2
|
02/02/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic carelink 2090 programmer |
2
|
02/02/2019
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic carelink encore 29901 programmer |
2
|
11/08/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
medtronic carelink 2090 programmer |
2
|
11/08/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
percepta crt-p mri surescan, ref w1tr01
product usage:
the crt-p models are implantable pulse ge |
2
|
07/10/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
percepta quad crt-p mri surescan, ref w4tr01
product usage:
the crt-p models are implantable pul |
2
|
07/10/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
percepta crt-p mri surescan, ref w1tr04
product usage:
the crt-p models are implantable pulse ge |
2
|
07/10/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
percepta quad crt-p mri surescan, ref w4tr04
product usage:
the crt-p models are implantable pul |
2
|
07/10/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
implantable cardioverter defibrillators (icds), evera. labeled as the following:
a. evera s dr icd |
1
|
02/01/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
cardiac resynchronization therapy defibrillators (crt-ds), claria mri. labeled as the following:
|
1
|
02/01/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
implantable cardioverter defibrillators (icds), evera mri. labeled as the following:
a. evera mr |
1
|
02/01/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
cardiac resynchronization therapy defibrillators (crt-ds), viva. labeled as the following:
a. vi |
1
|
02/01/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
implantable cardioverter defibrillators (icds), visia af mri. labeled as the following:
a. visia a |
1
|
02/01/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
implantable cardioverter defibrillators (icds), visia af. labeled as:
a. visia af vr icd df1 (pro |
1
|
02/01/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
cardiac resynchronization therapy defibrillators (crt-ds), compia mri. labeled as the following:
|
1
|
02/01/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
cardiac resynchronization therapy defibrillators (crt-ds), amplia mri. labeled as the following:
|
1
|
02/01/2018
|
medtronic inc., cardiac rhythm and heart failure (crhf)
|
accolade sr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
accolade dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
accolade el dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
accolade mri sr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
accolade mri dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
accolade mri el dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
valitude crt-p pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
valitude x4 crt-p pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
altrua 2 sr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
altrua 2 dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
altrua 2 el dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
visionist crt-p pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
visionist x4 crt-p pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
essentio sr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
essentio dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
essentio mri sr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
essentio mri dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
essentio el dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
essentio mri el dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
proponent sr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
proponent dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
proponent el dr pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
proponent vdd sl pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
proponent mri pacemaker |
2
|
01/15/2018
|
boston scientific corporation
|
medtronic, temporary pacing lead system, model 6416, sterile eo.
product catalog numbers:
five (5) |
2
|
09/19/2016
|
medtronic inc., cardiac rhythm and heart failure
|
tryx absorbable antibacterial envelope
product usage:
indicated for stabilization of implanted p |
2
|
08/15/2016
|
tyrx inc.
|
tryx antibacterial envelope rx only
product usage:
indicated for stabilization of implanted pace |
2
|
08/15/2016
|
tyrx inc.
|
tryx neuro absorbable antibacterial envelope
product usage:
indicated for stabilization of impla |
2
|
08/15/2016
|
tyrx inc.
|
medtronic insync iii, model 8042, 8042b and 8042u. implantable pulse generator pacemaker. |
2
|
11/27/2015
|
medtronic inc.
|
medtronic medical device identification card for surescan pacemaker patients. the front of |
2
|
10/05/2015
|
medtronic inc. cardiac rhythm disease management
|
medtronic dual chamber temporary external pacemaker, model 5392.
product usage:
the temporary |
2
|
03/31/2015
|
medtronic inc. cardiac rhythm disease management
|
medtronic temporary pacemaker, model 5348. single chamber external pulse generator (epg) temporary p |
2
|
05/24/2014
|
medtronic inc. cardiac rhythm disease management
|
medtronic, consulta¿ crt-p, model c4tr01, c3tr01 (not approved for us), and syncra¿ crt-p, model c |
2
|
06/27/2013
|
medtronic inc. cardiac rhythm disease management
|
medtronic, kappa 600
kdr600,kdr601,kdr603,kdr606,kdr651,kdr653
the devices are implantable pulse |
2
|
04/29/2011
|
medtronic inc. cardiac rhythm disease management
|
medtronic dual chamber temporary pacemaker, model 5388. manufacturer: medtronic, inc., 710 medtron |
2
|
11/22/2010
|
medtronic inc. cardiac rhythm disease managment
|
medtronic enrhythm, p1501dr, dual chamber rate responsive pacemaker with rapidread telemetry. the |
2
|
04/26/2010
|
medtronic inc. cardiac rhythm disease managment
|
medtronic sigma 100/200/300 series ipgs, dual chamber pacemaker, models sd203 and sd303. |
1
|
06/11/2009
|
medtronic inc. cardiac rhythm disease managment
|
medtronic kappa 600/700/900 series implantable pulse generator (ipgs), dual chamber atrial sensing, |
1
|
06/11/2009
|
medtronic inc. cardiac rhythm disease managment
|
medtronic sigma 100/200/300 series ipgs, single chamber pacemaker, model svvi103, for ventricular us |
1
|
06/11/2009
|
medtronic inc. cardiac rhythm disease managment
|
medtronic sigma 100/200/300 series ipgs, dual chamber atrial sensing, ventricular sensing and pacing |
1
|
06/11/2009
|
medtronic inc. cardiac rhythm disease managment
|
medtronic sigma 100/200/300 series ipgs, dual chamber rate responsive pacemaker, models dr353, sdr20 |
1
|
06/11/2009
|
medtronic inc. cardiac rhythm disease managment
|
medtronic kappa 600/700/900 series implantable pulse generator (ipgs), dual chamber rate responsive |
1
|
06/11/2009
|
medtronic inc. cardiac rhythm disease managment
|
medtronic kappa 600/700/900 series implantable pulse generator (ipgs), dual chamber pacemaker, model |
1
|
06/11/2009
|
medtronic inc. cardiac rhythm disease managment
|
medtronic sigma 100/200/300 series ipgs, single chamber rate responsive pacemaker; models sr353, ssr |
1
|
06/11/2009
|
medtronic inc. cardiac rhythm disease managment
|
medtronic kappa 600/700/900 series implantable pulse generator (ipgs), single chamber rate responsiv |
1
|
06/11/2009
|
medtronic inc. cardiac rhythm disease managment
|
medtronic sigma 100/200/300 series ipgs, single chamber pacemaker; models ss103, ss106, ss203, and s |
1
|
06/11/2009
|
medtronic inc. cardiac rhythm disease managment
|
maximo ii crt d284trk, for ventricular pacing and defibrillation. |
2
|
01/28/2009
|
medtronic inc. cardiac rhythm managment
|
medtronic maximo ii dr d28drg, for ventricular pacing and defibrillation. |
2
|
01/28/2009
|
medtronic inc. cardiac rhythm managment
|
medtronic maximo ii vr d284vrc, for ventricular pacing and defibrillation. |
2
|
01/28/2009
|
medtronic inc. cardiac rhythm managment
|
medtronic paceart system, 2006 edition, medtronic, inc. 710 medtronic parkway, minneapolis, mn 5543 |
3
|
11/06/2007
|
medtronic inc. cardiac rhythm managment
|
medtronic paceart 2004 second edition & paceart 2005 first edition versions of the paceart gateway s |
3
|
05/31/2006
|
medtronic inc. cardiac rhythm managment
|
sigma implantable pulse generators (ipgs) dual chamber rate responsive pacemaker, models sdr203, sdr |
2
|
02/18/2006
|
medtronic inc. cardiac rhythm managment
|
sigma implantable pulse generators (ipgs) dual chamber pacemaker, models sd203, sd303 |
2
|
02/18/2006
|
medtronic inc. cardiac rhythm managment
|
sigma implantable pulse generators (ipgs) dual chamber atrial sensing, ventricular sensing and pacin |
2
|
02/18/2006
|
medtronic inc. cardiac rhythm managment
|
sigma implantable pulse generators (ipgs) single chamber pacemaker model svvi103, for ventricular us |
2
|
02/18/2006
|
medtronic inc. cardiac rhythm managment
|
sigma implantable pulse generators (ipgs) single chamber pacemaker, models ss103, ss106, ss203, ss30 |
2
|
02/18/2006
|
medtronic inc. cardiac rhythm managment
|
sigma implantable pulse generators (ipgs) single chamber rate responsive pacemaker, models ssr203, s |
2
|
02/18/2006
|
medtronic inc. cardiac rhythm managment
|
kappa model 701 implantable pulse generators (ipgs) are pacemaker devices that provide therapies for |
2
|
07/20/2004
|
medtronic inc. cardiac rhythm managment
|
kappa model 901 implantable pulse generators (ipgs) are pacemaker devices that provide therapies for |
2
|
07/20/2004
|
medtronic inc. cardiac rhythm managment
|