Food, drugs, devices › Terumo Medical Corporation
Device recall: Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is
FDA enforcement event 79167 is a device recall by Terumo Medical Corporation of Elkton, MD, initiated 12 Sep 2017 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 31 Aug 2018. Initiation: voluntary: firm initiated. Terumo Medical Corporation has 8 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
Terumo Medical Corporation, Elkton, MD.
Reason for recall
"The tucking depth feature of this catheter introducer is marginally outside the upper specification."
Distribution
"To be added."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0725-2018 | Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries. | 33 | Class II | Terminated | 7 Mar 2018 |
Context
Other enforcement events for Terumo Medical Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Jun 2026 | GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to fac | Device | Class II | 1 |
| 26 Apr 2019 | SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, ST | Device | Class I | 3 |
| 8 Feb 2019 | Terumo Sur-vet Needle, 20G x 1", Product Code 100204 | Device | Class II | 9 |
| 16 Mar 2016 | PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O | Device | Class II | 1 |
| 6 Nov 2015 | Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human v | Device | Class II | 1 |
| 5 Aug 2015 | SurFlo IV Catheter | Device | Class II | 1 |
| 30 May 2013 | Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to fa | Device | Class II | 2 |
All 8 events for Terumo Medical Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The tucking depth feature of this catheter introducer is marginally outside the upper specification."
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: "To be added."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Aug 2018. "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.