FDA Device recall Z-0646-2022
Destino Twist 14F (also branded as Guidestar 14F)
- FDA Device
- Class II
- completed
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class II recall of Destino Twist 14F (also branded as Guidestar 14F) by Oscor, citing there is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0646-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2021-12-22 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Oscor |
| Distribution | PA, TN |
Product
Destino Twist 14F (also branded as Guidestar 14F)
Reason
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Identifiers
| code_info | 1) Model DST1405525 (Destino Twist 14F) - a) Lot: PQOC13475 [UDI: (01)00885672011123(11)211014(17)241001(10)PQOC134…1) Model DST1405525 (Destino Twist 14F) - a) Lot: PQOC13475 [UDI: (01)00885672011123(11)211014(17)241001(10)PQOC13475] 2) Model D141103 (Guidestar 14F) - Lots: a) DP14073 - [UDI: (01)00885672010911(11)211114(17)241101(10)DP14073] b) DP14072 - [UDI: (01)00885672010911(11)211024(17)241001(10)DP14072] c) DP14071 - [UDI: (01)00885672010911(11)211023(17)241001(10)DP14701] d) DP13834 - [UDI: (01)00885672010911(11)210919(17)240901(10)DP13834] e) DP13828 - [UDI: (01)00885672010911(11)210914(17)240901(10)DP13828] f) DP13827 - [UDI: (01)00885672010911(11)210826(17)240801(10)DP13827] g) DP13811 - [UDI: (01)00885672010911(11)210812(17)240801(10)DP13811] h) DP13812 - [UDI: (01)00885672010911(11)210812(17)240801(10)DP13812] i) PQOC12995 - [UDI: (01)00885672010911(11)210709(17)240701(10)PQOC12995] j) PQOC12632 - [UDI: (01)00885672010911(11)210706(17)240701(10)PQOC12632] k) PQOC12633 - [UDI: (01)00885672010911(11)210705(17)240701(10)PQOC12633] l) PQOC12345 - [UDI: (01)008856 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Other recalls by Oscor
- Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and acces…
FDA Device · Class I · 2026-07-22 · Oscor - Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
FDA Device · Class I · 2026-07-22 · Oscor - Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and…
FDA Device · Class I · 2026-07-22 · Oscor - AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads a…
FDA Device · Class II · 2021-04-07 · Oscor - TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart
FDA Device · Class I · 2018-11-14 · Oscor
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0646-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.