Food, drugs, devices › Medtronic Inc. Cardiac Rhythm Disease Management

Device recall: Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5

FDA enforcement event 65831 · Class II · initiated 17 Jul 2013 · status Terminated · terminated 4 Feb 2014

DeviceVoluntary: Firm initiated3 product recordsSaint Paul, MN

Medtronic Inc. Cardiac Rhythm Disease Management (Saint Paul, MN) initiated this device recall on 17 Jul 2013; FDA lists 3 product records under event 65831, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 4 Feb 2014. Initiation: voluntary: firm initiated. Medtronic Inc. Cardiac Rhythm Disease Management has 16 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN.

Reason for recall

"Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic."

Distribution

"Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2104-2013	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.	13223	Class II	Terminated	4 Sep 2013
Z-2105-2013	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.	217	Class II	Terminated	4 Sep 2013
Z-2106-2013	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 indicated for use in the extracorporeal circuit during…	758	Class II	Terminated	4 Sep 2013

Context

90%of 2013 device events are Class II1,236 events that year

3product records in this eventfirm median: 1

16events on this register for the firm

Other enforcement events for Medtronic Inc. Cardiac Rhythm Disease Management

Initiated	Product (first record)	Type	Class	Records
15 Sep 2015	Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the impl	Device	Class II	1
1 Sep 2015	Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.	Device	Class II	1
23 Mar 2015	Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BV	Device	Class II	1
17 Mar 2015	Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a c	Device	Class II	1
23 Feb 2015	Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used fo	Device	Class I	1
29 Apr 2014	Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI).	Device	Class II	1
30 Jan 2014	Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 787	Device	Class II	6
8 Jul 2013	Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the l	Device	Class II	1
14 Jun 2013	Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13:	Device	Class II	1
12 Jun 2013	Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F	Device	Class II	1

All 16 events for Medtronic Inc. Cardiac Rhythm Disease Management

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 4 Feb 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.