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.
Read the official notice →- Date
- 2022-06-08
- Country
- United States
- Brand
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Product
- The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AL, AR,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-08-17
USMedtronic 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…
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)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 → - 2022-03-23
- 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 → - 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 →
Other drugs & medical recalls in the United States
- 2022-06-08
- US
XVIVO PERFUSION AB recalls XVIVO Organ Chamber REF 19020
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
FDA · DeviceXVIVO PERFUSION ABU.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France,…Official notice → - US
Intuitive Surgical, Inc. recalls VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - US Nationwide and the countries/regions of Argentina,…Official notice → - US
Bio-Rad Laboratories, Inc. recalls Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in…
FDA · DeviceBio-Rad Laboratories, Inc.US: AZ, AR, GA, CO, TN, LA, VA, FL, KY, IN, KS, MD, MN, MO, NC, NJ, NY, OH,…Official notice → - US
Ion Beam Applications S.A. recalls Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other…
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose…
FDA · DeviceIon Beam Applications S.A.Worldwide distribution - US Nationwide distribution in the states of IL, VA,…Official notice → - US
Busse Hospital Disposables, Inc. recalls 3.2MM Pellet Insertion Tray Catalog Number: B9743
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the…
- US
Baxter Healthcare Corporation recalls 3,65 m Extension Set with Luer-lock Connector
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.Official notice →