Recall archive
28 recalls · page 1 of 2
Reported Jun 28, 2023
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Reason for recall — There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter…
119 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 17, 2022
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Reason for recall — There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
FDA (openFDA device enforcement)
Reported Jun 22, 2022
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Reason for recall — Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2022
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
FDA (openFDA device enforcement)
Reported Mar 23, 2022
LINQ II Insertable Cardiac Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — Devices may lose functionality due to susceptibility to moisture ingress.
FDA (openFDA device enforcement)
Reported Jan 12, 2022
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — There have been reports of stent migration.
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — The processing of collected episode data may fail due to a software error.
FDA (openFDA device enforcement)
Reported Nov 3, 2021
C315-HIS Delivery Catheter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Reason for recall — Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Medtronic Reveal LINQ LNQ11 / PA96000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report…
FDA (openFDA device enforcement)
Reported Jul 21, 2021
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
FDA (openFDA device enforcement)
Reported May 26, 2021
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
FDA (openFDA device enforcement)
Reported May 12, 2021
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 7, 2021
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Reason for recall — A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 3, 2021
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2020
CareLink SmartSync Device Manager, Model Number 24970A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 25, 2020
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2019
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Reason for recall — There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2019
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2019
Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
FDA (openFDA device enforcement)
Reported Feb 27, 2019
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic…
FDA (openFDA device enforcement)
Reported Feb 20, 2019
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 13, 2019
MEDTRONIC CARELINK 2090 programmer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the…
1 more product in this recall
FDA (openFDA device enforcement)
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