Recall archive
81 recalls · page 1 of 4
Reported Sep 25, 2024
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Reason for recall — Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen…
FDA (openFDA device enforcement)
Reported Jul 3, 2024
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
22 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — There is a potential for sterile package breach.
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone…
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Seal defects could compromise the ability of the product packaging to maintain sterility.
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Medtronic SynchroMed, Model A10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of…
FDA (openFDA device enforcement)
Reported Dec 6, 2023
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart…
FDA (openFDA device enforcement)
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 — 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 Sep 7, 2022
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
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 — 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 — 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 — 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 — The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
FDA (openFDA device enforcement)
Reported May 26, 2021
Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor…
19 more products in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
VenaSeal Closure System
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Inc.
Matched: Brand — Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery…
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 — 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)
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