Medtronic Perfusion Systems recalls Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD…
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke…
Read the official notice →- Date
- 2025-03-19
- Country
- United States
- Brand
- Medtronic Perfusion Systems
- Product
- Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA,…
- Classification
- Class I
- Units
- Domestic distribution nationwide. International distribution to the following…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Perfusion Systems recalls
- 2025-11-26
USMedtronic Perfusion Systems recalls MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go…
- 2025-11-19
- US
Medtronic Perfusion Systems recalls Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
- 2025-09-10
- US
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
The catheters may not retain their shape.
- 2025-01-29
- US
Medtronic Perfusion Systems recalls DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- 2024-11-13
- US
Medtronic Perfusion Systems recalls Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
FDA · DeviceMedtronic Perfusion SystemsUS: NY, OH, IL, NJ, MI, TN, WI, Australia, and SingaporeOfficial notice → - 2024-09-18
- US
Medtronic Perfusion Systems recalls Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide and the countries of Cambodia, Greece,…Official notice →
Other drugs & medical recalls in the United States
- 2025-03-19
- US
TruAbutment Inc. recalls Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software…
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
FDA · DeviceTruAbutment Inc.US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan,…Official notice → - US
Aesculap Inc recalls Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps…
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
FDA · DeviceAesculap IncDistribution was made nationwide and to PR. There was also government/military…Official notice → - US
CardioFocus, Inc. recalls CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an…
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
FDA · DeviceCardioFocus, Inc.Worldwide distribution - US Nationwide and the countries of Belgium, Czech…Official notice → - US
CareFusion 303, Inc. recalls BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
FDA · DeviceCareFusion 303, Inc.US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT,…Official notice → - US
GE Medical Systems, LLC recalls GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol)…
- US
Smiths Medical ASD, Inc. recalls Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035…
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.