Recall archive
444 recalls · page 3 of 19
Reported Jan 29, 2025
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ev3 Inc.
Matched: Product · Product details — There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
FDA (openFDA device enforcement)
Reported Jan 8, 2025
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Software issues were identified in application version 2.x.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neurosurgery
Matched: Brand — Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
FDA (openFDA device enforcement)
Reported Oct 30, 2024
SynchroMed II Infusion Pump. Product Number: 8637-20
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Potential for error and inability to interrogate pump due to data corruption in the pump memory.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
MEDLINE HEART CABG CDS, REF CDS983376R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Reason for recall — Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Vanta Implantable Neurostimulator (INS), Model 977006
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than…
FDA (openFDA device enforcement)
Reported Oct 18, 2024
Medtronic plc recalls Medtronic MiniMed™ 600 series or 700 series insulin pumps due to Device & Drug Safety - Defect
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Medtronic PLC
Matched: Brand · Product · Product details — Device & Drug Safety - Defect
FDA (recalls & safety alerts)
Reported Oct 16, 2024
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation…
FDA (openFDA device enforcement)
Reported Oct 9, 2024
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic MiniMed, Inc.
Matched: Brand — Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Reason for recall — Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen…
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage…
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand · Product · Product details — Product was distributed past expiration date.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
TourniKwik Tourniquet Set (CFN 79012)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Xomed, Inc.
Matched: Brand — Potential for false negative response on the NIM Vital Nerve Monitoring System
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue…
FDA (openFDA device enforcement)
Reported Jul 3, 2024
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
22 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand — Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay,…
FDA (openFDA device enforcement)
Reported May 22, 2024
Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Potential for unsealed sterile packing.
12 more products in this recall
FDA (openFDA device enforcement)
Reported May 15, 2024
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand — Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point"…
FDA (openFDA device enforcement)
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