Medtronic, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000019977 FEI 3015544746
Medtronic, Inc. is a medical device manufacturer based in the United States, with 31,830 devices listed and 327 FDA recalls as of 12 Nov 2026.
- Devices
- 31,830
- Registrations
- EUDAMEDFDA
- FDA recalls
- 32768 ongoing since 2021 (83 open in total)
Registry facts
- Registries
- FDA GUDID 1,990
- EUDAMED 1,913
- FDA 510(k) 8
- Device classes
- FDA Class II 1,664
- EU Class III 384
- EU Class IIa 356
- EU AIMDD 263
- FDA Class III 216
- FDA Class I 49
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Medtronic B.V. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000019977
- FDA FEI 3015544746
- DUNS 006261481
At a glance
EU certificates
32 of 32 in force.
Market reach
- European Union
- EUDAMED actor, 32 certificates
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Medtronic B.V.NL
What Medtronic, Inc. makes
Medtronic, Inc. manufactures a range of medical devices including vascular guide-catheters, peripheral and coronary angioplasty balloon catheters, and angiographic catheters. Their portfolio also includes cardiopulmonary bypass and extracorporeal membrane oxygenation cannulas, drug-eluting coronary artery stents, mitral and tricuspid annuloplasty rings, and cardiopulmonary bypass system blood tubing sets.
The company is based in the United States, and its products are categorized under Class I, Class II, Class III, Class IIb, and unclassified designations. These devices are listed in the EUDAMED, FDA 510(k), and FDA UDI registries.
Catalogue
Search and filter all 31,830 devicesShowing 1-50 of 31,830
Company details
- EUDAMED SRN
- US-MF-000019977
- SRN (system / procedure pack)
- US-PR-000014548
- FDA FEI number
- 3015544746
- DUNS number
- 006261481
- EUDAMED status
- Active
- EUDAMED registered name
- Medtronic, Inc.
- Registered address
- 710, Medtronic Parkway, MN 55432, Minneapolis, United States
- Phone
- +1(800)633-8766
- PRRC contact
- Jason Feipel
1 more person
- Rita Guzzetta
EUDAMED certificates
32 certificates32 valid, 0 expiredMDR 32next expiry 30 Nov 2026
TÜV SÜD Product Service GmbH 0123 18 certificates
- G70 039709 1361 Active
Technical documentation EU MDR
- Issued
- 10 Jun 2026
- Expires
- 9 Sep 2031
- Valid from
- 10 Sep 2026
- G70 039709 1366 Active
Technical documentation EU MDR
- Issued
- 10 Jul 2026
- Expires
- 7 Sep 2031
- Valid from
- 8 Sep 2026
- G70 039709 1577 Active
Technical documentation EU MDR
- Issued
- 7 Sep 2026
- Expires
- 6 Sep 2031
- G70 039709 1362 Active
Technical documentation EU MDR
- Issued
- 2 Jun 2026
- Expires
- 1 Sep 2031
- Valid from
- 2 Sep 2026
- G70 039709 1363 Active
Technical documentation EU MDR
- Issued
- 4 Aug 2026
- Expires
- 1 Sep 2031
- Valid from
- 2 Sep 2026
- G70 039709 1573 Active
Technical documentation EU MDR
- Issued
- 20 Aug 2026
- Expires
- 19 Aug 2031
- G15 039709 1576 Active
Quality management system EU MDR
- Issued
- 29 Jul 2026
- Expires
- 28 Jul 2031
- G15 039709 1576 Active
Quality management system EU MDR
- Issued
- 21 Sep 2026
- Expires
- 28 Jul 2031
- G15 039709 1560 Active
Quality management system EU MDR
- Issued
- 13 Aug 2026
- Expires
- 2 Jul 2030
- Valid from
- 1 Oct 2026
- G70 039709 1296 Active
Technical documentation EU MDR
- Issued
- 15 Jun 2026
- Expires
- 2 Jul 2030
- Reason
- Change approved
- G70 039709 1513 Active
Technical documentation EU MDR
- Issued
- 10 Aug 2026
- Expires
- 16 Dec 2029
- Reason
- Add device or group
- G70 039709 1509 Active
Technical documentation EU MDR
- Issued
- 15 Jun 2026
- Expires
- 27 Dec 2028
- Reason
- Add device or group
- G70 039709 1443 Active
Technical documentation EU MDR
- Issued
- 15 Jun 2026
- Expires
- 13 Aug 2028
- Reason
- Change approved
- G10 039709 1477 Active
Quality management system EU MDR
- Issued
- 2 Jun 2023
- Expires
- 1 Jun 2028
- G70 039709 1510 Active
Technical documentation EU MDR
- Issued
- 30 Jul 2026
- Expires
- 26 Jan 2028
- Reason
- Add device or group
- G70 039709 1408 Active
Technical documentation EU MDR
- Issued
- 10 May 2024
- Expires
- 17 Nov 2027
- G70 039709 1410 Expiring
Technical documentation EU MDR
- Issued
- 22 Sep 2026
- Expires
- 14 Jul 2027
- Reason
- Change approved
- G10 039709 1455 Expiring
Quality management system EU MDR
- Issued
- 6 Apr 2023
- Expires
- 30 Nov 2026
BSI Group The Netherlands B.V. 2797 9 certificates
- MDR 734737 Active
Quality management system EU MDR
- Issued
- 29 Jul 2026
- Expires
- 12 Sep 2031
- Valid from
- 13 Sep 2026
- MDR 731827 Active
Quality management system EU MDR
- Issued
- 7 Jul 2026
- Expires
- 25 Aug 2031
- Valid from
- 26 Aug 2026
- MDR 731886 Active
Technical documentation EU MDR
- Issued
- 24 Jun 2026
- Expires
- 25 Aug 2031
- Valid from
- 26 Aug 2026
- MDR 730827 Active
Quality management system EU MDR
- Issued
- 4 Jun 2026
- Expires
- 19 Jul 2031
- Valid from
- 20 Jul 2026
- MDR 730924 Active
Technical documentation EU MDR
- Issued
- 4 Jun 2026
- Expires
- 19 Jul 2031
- Valid from
- 20 Jul 2026
- MDR 773917 Active
Technical documentation EU MDR
- Issued
- 19 Oct 2026
- Expires
- 5 Sep 2029
- Reason
- Change approved
- MDR 731949 Active
Technical documentation EU MDR
- Issued
- 30 Jul 2026
- Expires
- 9 Jul 2028
- Reason
- Change approved
- MDR 755604 Active
Technical documentation EU MDR
- Issued
- 30 Jul 2026
- Expires
- 9 Jul 2028
- Reason
- Change approved
- MDR 767838 Active
Technical documentation EU MDR
- Issued
- 30 Jul 2026
- Expires
- 25 May 2028
- Reason
- Change approved
DEKRA Certification B.V. 0344 3 certificates
- 2266041TD02 Active
Technical documentation EU MDR
- Issued
- 4 Jun 2026
- Expires
- 1 Dec 2029
- Reason
- Change approved
- 2250280TD06 Expiring
Technical documentation EU MDR
- Issued
- 1 Jul 2022
- Expires
- 1 Jul 2027
- 2250280TD07 Expiring
Technical documentation EU MDR
- Issued
- 19 Jul 2022
- Expires
- 1 Jul 2027
DQS Medizinprodukte GmbH 0297 2 certificates
- 1000225868 Active
Quality management system EU MDR
- Issued
- 9 Jun 2026
- Expires
- 8 Jun 2031
- 1000277712 Active
Technical documentation EU MDR
- Issued
- 9 Jun 2026
- Expires
- 8 Jun 2031
FDA recalls
FDA recall records list 323 recalls initiated by MEDTRONIC, INC., the earliest on 2003-01-31 and the most recent on 2026-03-11. By recorded status: 79 ongoing, 242 terminated and 2 with another status. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, packaging, electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 26
- 2018 6
- 2019 10
- 2020 7
- 2021 22
- 2022 6
- 2023 6
- 2024 25
- 2025 7
- 2026 5
2026
- 24 Sep 2026 Z-0302-2027 Not yet classified Ongoing Software problem has the potential for an inaccurate displayed longevity estimate.
- 24 Sep 2026 Z-0303-2027 Not yet classified Ongoing Software problem has the potential for an inaccurate displayed longevity estimate.
- 24 Sep 2026 Z-0304-2027 Not yet classified Ongoing Software problem has the potential for an inaccurate displayed longevity estimate.
- 17 Sep 2026 Z-0285-2027 Not yet classified Ongoing Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.
Full distribution text
- 11 Mar 2026 Z-1948-2026 Class II Ongoing Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
2025
- 4 Dec 2025 Z-1098-2026 Class II Ongoing Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Full distribution text
- 29 Oct 2025 Z-0726-2026 Class II Ongoing There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
- 18 Jun 2025 Z-2168-2025 Class II Ongoing In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
- 18 Jun 2025 Z-2169-2025 Class II Ongoing In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
- 17 Jun 2025 Z-2127-2025 Class II Ongoing A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
- 4 Dec 2025 Z-1098-2026 Class II Ongoing Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Show the 25 most recent of 327 recalls
2025
- 17 Jun 2025 Z-2128-2025 Class II Ongoing A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
- 29 Apr 2025 Z-1924-2025 Class II Ongoing Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
2024
- 11 Jul 2024 Z-3152-2024 Class II Ongoing Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.
- 16 Apr 2024 Z-2190-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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- 16 Apr 2024 Z-2191-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Full distribution text
- 16 Apr 2024 Z-2192-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Full distribution text
- 16 Apr 2024 Z-2193-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Full distribution text
- 16 Apr 2024 Z-2194-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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- 16 Apr 2024 Z-2195-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Full distribution text
- 16 Apr 2024 Z-2196-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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- 16 Apr 2024 Z-2197-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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- 16 Apr 2024 Z-2198-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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- 16 Apr 2024 Z-2199-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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- 16 Apr 2024 Z-2200-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Full distribution text
- 16 Apr 2024 Z-2201-2024 Class II Ongoing Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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Frequently asked questions
How many devices does MEDTRONIC, INC. have in the registry?
The registry currently lists 31830 devices for MEDTRONIC, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list MEDTRONIC, INC.'s devices?
Among its 50 most recently registered devices, MEDTRONIC, INC. has devices listed in EUDAMED (48 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do MEDTRONIC, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for MEDTRONIC, INC.'s devices are Class I, Class II, Class III and active implantable (AIMDD). Each device page shows its own class and authorisation.
Are there FDA recall records for MEDTRONIC, INC.?
FDA recall records list 327 recalls initiated by MEDTRONIC, INC., the most recent initiated on 24 Sep 2026. 83 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for MEDTRONIC, INC.?
EUDAMED lists 32 certificates for MEDTRONIC, INC. (quality management system; technical documentation) under MDR. 10 are recorded with the status issued. The most recent was issued on 19 Oct 2026.
What are the newest devices from MEDTRONIC, INC. in the registry?
The most recently registered devices listed for MEDTRONIC, INC. include BB11A61R10, CapSureFix™ Novus, RF MARINR™ and ACHIEVE™.