Medtronic Inc. Cardiac Rhythm Disease Management

FDA recalling firm · 16 enforcement events · 23 product records · 2012–2015 · MN

Medtronic Inc. Cardiac Rhythm Disease Management has 16 FDA enforcement events on this register (23 product records) between 2012 and 2015: 16 device; the busiest year was 2013 with 8.

6% of its events are Class I; the most common class is Class II (15). 0 events are listed as ongoing; the recalling firm's address is in MN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
15 Sep 2015	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 messaging regarding the MR conditional status of the…	Device	Class II	1	Terminated
1 Sep 2015	Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.	Device	Class II	1	Terminated
23 Mar 2015	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, EUT808015, EUT808030, EUT812015,…	Device	Class II	1	Terminated
17 Mar 2015	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 where short-term demand (synchronous) or…	Device	Class II	1	Terminated
23 Feb 2015	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.	Device	Class I	1	Terminated
29 Apr 2014	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 connected to temporary transvenous, epicardial or…	Device	Class II	1	Terminated
30 Jan 2014	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 wire-wound PVC bodies with angled, beveled tips.…	Device	Class II	6	Terminated
17 Jul 2013	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 cardiopulmonary surgery.	Device	Class II	3	Terminated
8 Jul 2013	Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.	Device	Class II	1	Terminated
14 Jun 2013	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, nonpyrogenic devices designed to filter microemboli…	Device	Class II	1	Terminated
12 Jun 2013	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 intended to be used in the coronary or…	Device	Class II	1	Terminated
7 Jun 2013	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.	Device	Class II	1	Terminated
13 Mar 2013	Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.	Device	Class II	1	Terminated
13 Mar 2013	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 during diagnostic or interventional procedures…	Device	Class II	1	Terminated
19 Feb 2013	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.	Device	Class II	1	Terminated
19 Nov 2012	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, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1,…	Device	Class II	1	Terminated

By type and class

Device16

Class II15

Class I1

Class I: 6% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Medtronic Inc. Cardiac Rhythm Disease Management by year initiated.

Questions and answers

How many FDA recalls has Medtronic Inc. Cardiac Rhythm Disease Management had?

16 enforcement events (23 product records) on this register, 2012–2015: 16 device.

Are any Medtronic Inc. Cardiac Rhythm Disease Management recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Medtronic Inc. Cardiac Rhythm Disease Management recalls?

15 Class II, 1 Class I. 6% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.