Food, drugs, devices › Oscor Inc.
Device recall: Destino Twist 14F (also branded as Guidestar 14F)
Oscor Inc. (Palm Harbor, FL) initiated this device recall on 22 Dec 2021; FDA lists 1 product record under event 89392, 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. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated. Oscor Inc. has 7 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
Oscor Inc., Palm Harbor, FL.
Reason for recall
"There is potential for separation between the threaded hub and threaded cap at the proximal end of the device."
Distribution
"Distribution to TN and PA in USA OUS distribution to Czech Republic"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0646-2022 | Destino Twist 14F (also branded as Guidestar 14F) | 549 units | Class II | Completed | 23 Feb 2022 |
Context
Other enforcement events for Oscor Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Jun 2026 | Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13 | Device | Class I | 3 |
| 10 Mar 2021 | AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various type | Device | Class II | 1 |
| 26 Sep 2018 | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Hea | Device | Class I | 1 |
| 31 Mar 2017 | ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable | Device | Class I | 2 |
| 5 Oct 2016 | OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters | Device | Class II | 30 |
| 25 Jul 2012 | Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is potential for separation between the threaded hub and threaded cap at the proximal end of the device."
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: "Distribution to TN and PA in USA OUS distribution to Czech Republic"
Is the recall still ongoing?
FDA lists the status as Completed. "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.