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.
Read the official notice →- Date
- 2021-11-03
- Country
- United States
- Brand
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Product
- C315-HIS Delivery Catheter
- Classification
- Class II
- Units
- Distributed internationally to Australia, Brunei Darussalam, China, Germany,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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 →- 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 →- 2021-12-01
US
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.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Worldwide distribution - US Nationwide. There was military/government…Official notice →
Other drugs & medical recalls in the United States
- 2021-11-03
US
Olympus Corporation of the Americas recalls ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple…
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and…
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution to states of: AL, CA, CT, FL, IL, MD, MI, MN, MO,…Official notice →US
AB SCIEX recalls Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem…
The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may lead to the user making…
FDA · DeviceAB SCIEXWorldwide distribution - US Nationwide distribution in the states of District…Official notice →US
Xstrahl Limited recalls Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray…
If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible…
FDA · DeviceXstrahl LimitedWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →US
W L Gore & Associates, Inc. recalls REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr,…
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
FDA · DeviceW L Gore & Associates, Inc.US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD,…Official notice →US
Smiths Medical ASD Inc. recalls Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Two devices were labeled with the same serial number
US
MEDTECH SAS recalls ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to…
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the…
FDA · DeviceMEDTECH SASUS Nationwide distribution and International Distribution to countries of:…Official notice →