Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management

23 recalls in our database name Medtronic Inc. Cardiac Rhythm Disease Management as the manufacturing or recalling firm.

What the numbers show

Total: 23
Critical: 0
Severe: 5
Most recent: 2015-10-14

Of the 23 recalls from Medtronic Inc. Cardiac Rhythm Disease Management we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (22%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–23 of 23

ModerateFDA (Devices)·Z-0022-2016·2015-10-14
Medtronic SureScan Pacemaker ID Cards Mislabel MR Conditional Status
Medtronic is recalling 777 identification cards for SureScan pacemaker patients that incorrectly indicate the entire system is MR Conditional.
Product
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2777-2015·2015-09-23
Medtronic CryoConsole Recalled Due to USB Component Issue
Medtronic is recalling 103 CryoConsole units because a USB memory component issue can result in extended procedure time during cardiac ablation.
Product
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1356-2015·2015-04-08
Medtronic Temporary Pacemaker Recalled for Battery Connection Failure
Medtronic is recalling 6,040 Model 5392 temporary pacemakers because specific AA batteries may fail to connect, potentially stopping pacing therapy.
Product
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1365-2015·2015-04-08
Medtronic Recalls Trellis 6 and 8 Peripheral Infusion Systems for Sterility Breach
Medtronic is voluntarily recalling Trellis 6 and 8 Peripheral Infusion Systems due to potential sterility breaches in the outer packaging.
Product
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EU
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1276-2015·2015-03-25
Medtronic FlexCath Select Steerable Sheath Recalled for Valve Debris
Medtronic is recalling 151 FlexCath Select Steerable Sheaths because clinicians observed debris originating from the hemostasis valve outside of patients' bodies.
Product
Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1661-2014·2014-06-04
Medtronic Temporary Pacemaker Recalled for Pacing Rate Defect
Medtronic is recalling 16,337 temporary pacemakers worldwide because oxidation on internal contacts can cause the pacing rate to increase unexpectedly to 180 pulses per minute.
Product
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connecte
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1000-2014·2014-02-26
Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Splitting
Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.
Product
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified b
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0995-2014·2014-02-26
Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D Arterial Cannulae because the device body may split near the suture collar.
Product
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0999-2014·2014-02-26
Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.
Product
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0996-2014·2014-02-26
Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.
Product
Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0998-2014·2014-02-26
Medtronic Recalls Select CAP Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select CAP Arterial Cannulae because the cannula body may split near the suture collar. The devices are used for short-term cardiopulmonary bypass.
Product
Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0997-2014·2014-02-26
Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.
Product
Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2013·2013-09-04
Medtronic Perfusion Tubing Packs Recalled Due to Suction Wand Issue
Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.
Product
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2104-2013·2013-09-04
Medtronic Perfusion Tubing Packs Recalled Due to Defective Suction Wand
Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands recalled by Edwards Lifesciences.
Product
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2106-2013·2013-09-04
Medtronic Perfusion Tubing Packs Recalled Due to Component Issue
Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.
Product
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indica
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1966-2013·2013-08-21
Medtronic Recalls Pediatric Arterial Filters Due to Potential Media Breach
Medtronic is recalling 148 Affinity Pediatric Arterial Filters because a small breach in the filter media may allow unwanted particulate or gaseous emboli to pass through, posing a risk of serious injury or death to pediatric patients.
Product
Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyro
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1876-2013·2013-08-14
Medtronic Mullins Transseptal Catheter Sheath Recall for Labeling Error
Medtronic is recalling specific lots of Mullins Transseptal Catheter Introducer Sheaths because packages labeled as 7F may contain 8F dilators.
Product
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1607-2013·2013-07-03
Medtronic Recalls Specific CRT-P Pacemakers for Potential Malfunction
Medtronic is recalling specific Consulta and Syncra CRT-P pacemakers manufactured in April and May 2013 due to a production issue that could cause malfunction. No device failures have been reported.
Product
Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
Category
Medical Device
Distribution
25 states
ModerateFDA (Devices)·Z-1564-2013·2013-07-03
Medtronic Launcher Guiding Catheter Recalled for Labeling Errors
Medtronic is recalling 24 units of Launcher Guiding Catheters because the packaging labels do not accurately reflect the catheters inside.
Product
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is i
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1019-2013·2013-04-03
Medtronic Archer Super Stiff Guidewires Recalled for Potential Kinking and Breaking
Medtronic is recalling specific Archer Super Stiff Guidewires due to a manufacturing defect that may cause the device to kink or break during use.
Product
Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1017-2013·2013-04-03
Medtronic Archer Super Stiff Guidewire Recalled for Coating Separation Risk
Medtronic is recalling Archer Super Stiff Guidewires because the PTFE coating may separate from the wire during use.
Product
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0908-2013·2013-03-13
Medtronic DPL Single Stage Venous Cannula Recalled for Rough Metal Edges
Medtronic is recalling DPL Single Stage Venous Cannulas used in cardiopulmonary bypass due to potential rough metal edges on the tip side ports.
Product
Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0618-2013·2013-01-09
Medtronic Intersept Custom Tubing Packs Recalled for Packaging Damage
Medtronic is recalling Intersept Custom Tubing Packs because packaging trays may be damaged, compromising product sterility.
Product
Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M1
Category
Medical Device
Distribution
Distributed nationwide