Recall archive
453 recalls · page 8 of 19
Reported Oct 27, 2021
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand · Product · Product details — There was an increase in complaints related to tip breaks and wobble/vibration.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Engraving on implants may not match what is listed on the pouch labels.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
FDA (openFDA device enforcement)
Reported Sep 29, 2021
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Potential for a wire protrusion through the left heart vent catheter tip
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Medtronic HVAD Pump Implant Kits
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
Matched: Product · Product details — There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair…
FDA (openFDA device enforcement)
Reported Aug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1103
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware, Inc.
Matched: Reason for recall — Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Excess nylon flash on the clip.
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile…
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Medtronic Reveal LINQ LNQ11 / PA96000
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 — Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report…
FDA (openFDA device enforcement)
Reported Jul 21, 2021
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
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 — Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
FDA (openFDA device enforcement)
Reported Jul 14, 2021
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Heart Valves Division
Matched: Brand — Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand — Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Specific lots may have been manufactured with insufficient or incomplete welds.
24 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
Matched: Brand — The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped…
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA, Inc.
Matched: Brand — Product is impacted by a thread profile defect due to a manufacturing issue.
FDA (openFDA device enforcement)
Reported Jun 9, 2021
MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Minimed
Matched: Brand — Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 26, 2021
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand — The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
FDA (openFDA device enforcement)
Reported May 26, 2021
Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor…
19 more products in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
VenaSeal Closure System
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Inc.
Matched: Brand — Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery…
FDA (openFDA device enforcement)
Reported May 12, 2021
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
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 SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month…
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 12, 2021
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — Incorrect size printed on the device; packaging is labeled correctly.
FDA (openFDA device enforcement)
Reported May 12, 2021
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
FDA (openFDA device enforcement)
Reported Apr 28, 2021
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Heartware, Inc.
Matched: Reason for recall — Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation,…
2 more products in this recall
FDA (openFDA device enforcement)
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