Drugs & medicalClass II

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.

Read the official notice →
Date
2025-01-29
Country
United States
Brand
Medtronic Perfusion Systems
Product
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Classification
Class II
Units
Worldwide - US Nationwide 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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2025-11-19
  2. US
    Drugs & medicalClass II

    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.

    FDA · DeviceMedtronic Perfusion SystemsUS States: AZ, CA, TNOfficial notice →
  3. 2025-09-10
  4. US
    Drugs & medicalClass I

    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.

    FDA · DeviceMedtronic Perfusion SystemsWorldwide - US Nationwide distribution.Official notice →
  5. 2025-03-19
  6. US
    Drugs & medicalClass I

    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…

    FDA · DeviceMedtronic Perfusion SystemsDomestic distribution nationwide. International distribution to the following…Official notice →
  7. 2024-11-13
  8. US
    Drugs & medicalClass II

    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 →
  9. 2024-09-18
  10. US
    Drugs & medicalClass II

    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 →
  11. 2024-07-31
  12. US
    Drugs & medicalClass II

    Medtronic Perfusion Systems recalls TourniKwik Tourniquet Set (CFN 79012)

    Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.

    FDA · DeviceMedtronic Perfusion SystemsWorldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and…Official notice →
All 21 Medtronic Perfusion Systems recalls →

Other drugs & medical recalls in the United States

  1. 2025-01-29
  2. US
    Drugs & medicalClass II

    MICROVENTION INC. recalls Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846

    Sterility assurance; microcatheter inner packaging may contain incomplete seal.

    FDA · DeviceMICROVENTION INC.US: None OUS: ChinaOfficial notice →
  3. US
    Drugs & medicalClass II

    St. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care…

    As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

    FDA · DeviceSt. Jude MedicalWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →
  4. US
    Drugs & medicalClass II

    St. Jude Medical recalls Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System…

    Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.

    FDA · DeviceSt. Jude MedicalU.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/AOfficial notice →
  5. US
    Drugs & medicalClass II

    O&M HALYARD, INC. recalls Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack…

    Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

    FDA · DeviceO&M HALYARD, INC.US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS,…Official notice →
  6. US
    Drugs & medicalClass II

    Stryker Corporation recalls stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

    There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).

    FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of UK, Netherlands,…Official notice →
  7. US
    Drugs & medicalClass II

    Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant…

    Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

    FDA · DeviceIntegra LifeSciences Corp.US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA,…Official notice →
See all drugs & medical recalls →