Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b.…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy…
Read the official notice →- Date
- 2022-08-17
- Country
- United States
- Brand
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Product
- Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1,…
- Classification
- Class I
- Units
- Worldwide Distribution
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-06-28
USMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators…
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)US Nationwide - Worldwide DistributionOfficial notice →- 2022-08-03
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)US Nationwide distribution in the states of Indiana and CA.Official notice → - 2022-06-22
- US
Medtronic 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
- US
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
- US
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 →
Other drugs & medical recalls in the United States
- 2022-08-17
- US
Corin Ltd recalls Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
- US
Alere San Diego, Inc. recalls The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol,…
Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or…
FDA · DeviceAlere San Diego, Inc.US: IL, NV, FL, LA, CA, MA, MN, NC, AK, NE, TX, PA, RI, SC, TN, OK, KY, GA,…Official notice → - US
Guangdong Haiou Medical Apparatus Co., Ltd recalls Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable…
Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick…
FDA · DeviceGuangdong Haiou Medical Apparatus Co., LtdUS Nationwide distribution in the state of CA.Official notice → - US
Haimen Shengbang Laboratory Equipment Co. Ltd. recalls HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
Distributed VTM outside of VTM Guidance and without clearance.
FDA · DeviceHaimen Shengbang Laboratory Equipment Co. Ltd.Worldwide distribution - US Nationwide distribution in the states of CA, FL,…Official notice → - US
Teva Pharmaceuticals USA Inc recalls Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories,…
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
- US