Food, drugs, devices › Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Device recall: C315-HIS Delivery Catheter

FDA enforcement event 88688 · Class II · initiated 9 Sep 2021 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordMounds View, MN

FDA enforcement event 88688 is a device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) of Mounds View, MN, initiated 9 Sep 2021 and classified Class II, with 1 product record.

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. 89% of the 900 device enforcement events initiated in 2021 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 30 enforcement events on this register, with a median of 2 product records 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 and Heart Failure (CRHF), Mounds View, MN.

Reason for recall

"Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter."

Distribution

"Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0173-2022	C315-HIS Delivery Catheter	591 units	Class II	Ongoing	3 Nov 2021

Context

89%of 2021 device events are Class II900 events that year

1product record in this eventfirm median: 2

30events on this register for the firm

Other enforcement events for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Initiated	Product (first record)	Type	Class	Records
10 May 2023	ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators	Device	Class I	120
22 Jun 2022	Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR IC	Device	Class I	6
20 Apr 2022	The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure,	Device	Class II	1
12 Apr 2022	Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA	Device	Class II	2
18 Jan 2022	LINQ II Insertable Cardiac Monitor	Device	Class II	1
19 Nov 2021	Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.	Device	Class II	1
8 Nov 2021	Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72	Device	Class II	2
12 Oct 2021	Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Cr	Device	Class II	1
1 Jun 2021	Medtronic Reveal LINQ LNQ11 / PA96000	Device	Class II	1
14 May 2021	Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only	Device	Class II	1

All 30 events for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter."

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: "Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan."

Is the recall still ongoing?

FDA lists the status as Ongoing. "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.