Recall archive
444 recalls · page 9 of 19
Reported Feb 10, 2021
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware, Inc.
Matched: Product · Product details — Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in…
FDA (openFDA device enforcement)
Reported Feb 3, 2021
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 27, 2021
REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details — Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 20, 2021
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency…
FDA (openFDA device enforcement)
Reported Jan 20, 2021
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
FDA (openFDA device enforcement)
Reported Jan 6, 2021
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details — There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 23, 2020
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
FDA (openFDA device enforcement)
Reported Dec 16, 2020
Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Heart Valves Division
Matched: Brand — Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 9, 2020
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Missing solder battery connection, which could interrupt power of insulin pump.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 2, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Ats Medical, Inc.
Matched: Brand — There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2020
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
Matched: Brand — Subsequent failure of catheters in the field and failed quality testing
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2020
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped…
FDA (openFDA device enforcement)
Reported Aug 5, 2020
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation…
FDA (openFDA device enforcement)
Reported Jul 29, 2020
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2020
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was…
FDA (openFDA device enforcement)
Reported Jul 15, 2020
CareLink SmartSync Device Manager, Model Number 24970A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2020
Extra corporeal circuit with bio-active surface.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Affected products failed a sterilization test.
FDA (openFDA device enforcement)
Reported Jun 24, 2020
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product details — Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2020
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling…
FDA (openFDA device enforcement)
Reported Jun 10, 2020
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than…
FDA (openFDA device enforcement)
Reported Jun 3, 2020
Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or…
FDA (openFDA device enforcement)
Reported Jun 3, 2020
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular Galway dba Medtronic Ireland
Matched: Brand · Product · Product details — Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
FDA (openFDA device enforcement)
Reported May 27, 2020
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of…
FDA (openFDA device enforcement)
Reported May 20, 2020
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Nonconforming product; length of the product measured shorter than the labeled length.
FDA (openFDA device enforcement)
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