Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following…
The processing of collected episode data may fail due to a software error.
Read the official notice →- Date
- 2021-12-01
- Country
- United States
- Brand
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Product
- Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide. There was military/government…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medtronic Inc., Cardiac Rhythm and Heart Failure recalls
- 2022-06-22
USMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR:…
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL GA, HI, IA,…Official notice →- 2022-06-08
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the…
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Worldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - 2022-03-23
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls LINQ II Insertable Cardiac Monitor
Devices may lose functionality due to susceptibility to moisture ingress.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Worldwide distribution - US Nationwide distribution in the states of NJ, NY,…Official notice → - 2022-01-12
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
There have been reports of stent migration.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Distribution was nationwide. There was also military/government distribution.…Official notice → - 2021-12-22
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)US, Canada, Northern Mariana IslandsOfficial notice → - 2021-11-03
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls C315-HIS Delivery Catheter
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
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Other drugs & medical recalls in the United States
- 2021-12-01
- US
Medtronic Vascular, Inc. recalls Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT…
Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
FDA · DeviceMedtronic Vascular, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL,…Official notice → - US
Medtronic Vascular, Inc. recalls Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
FDA · DeviceMedtronic Vascular, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient…
- US
Philips North America Llc recalls Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or…
Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or…
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Instrumentation Laboratory recalls HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or…
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
Intuitive Surgical, Inc. recalls The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision…
Incorrect expiration date on its package labeling (shipper box and inner carton label).
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