Destino Twist 14F (also branded as Guidestar 14F) recallZ-0646-2022 · Oscor Inc. · initiated Dec 22, 2021
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Oscor Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
FDA root cause category: Process control
What the company is doing
Oscor issued customer letters to impacted consignees on January 7 and 11, 2022. Distributors are asked to immediately check inventory for affected product and quarantine any recalled devices. All downstream customers (hospitals/end users) should be identified and this recall should be communicated to those customers immediately. All retrieved inventory is to be returned to Oscor. An acknowledgement form must be completed and returned to Oscor via fax (727-934-9835) or via email to [email protected].
Recall details
- Recall number
- Z-0646-2022
- Status
- Completed
- Initiated by the company
- Dec 22, 2021
- Recalling firm
- Oscor Inc.
- Quantity
- 549 units
- Product code
- DYB
- FDA submissions
- K140406
- Distribution
- Distribution to TN and PA in USA OUS distribution to Czech Republic
Product description
Destino Twist 14F (also branded as Guidestar 14F)
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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)00885672010911(11)210622(17)240601(10)PQOC12345] m) PQOC12330 - [UDI: (01)00885672010911(11)210602(17)240601(10)PQOC12330]
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Guidestar™ Steerable Guiding Sheath D141103Oscor Inc. · INTRODUCER, CATHETER1 recall1 death60 reports
- Destino Twist Steerable Guiding Sheath DST1405525Oscor Inc. · INTRODUCER, CATHETER1 recall0 reports
Product lines
Other devices under the same FDA submission
23 devices cleared under K140406 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Guidestar™ Steerable Guiding Sheath D141101Oscor Inc. · INTRODUCER, CATHETER43 reports
- Destino Twist Steerable Guiding Sheath DST0655509Oscor Inc. · INTRODUCER, CATHETER6 reports
- Destino Twist Steerable Guiding Sheath DCT1357125NMOscor Inc. · INTRODUCER, CATHETER6 reports
- Destino Twist Steerable Guiding Sheath DST0704509Oscor Inc. · INTRODUCER, CATHETER5 reports
- Destino Twist Steerable Guiding Sheath DST0705509Oscor Inc. · INTRODUCER, CATHETER5 reports
- Destino Twist Steerable Guiding Sheath DST0654509Oscor Inc. · INTRODUCER, CATHETER4 reports
- Destino Twist Steerable Guiding Sheath DST0654509TDOscor Inc. · INTRODUCER, CATHETER2 reports
- Destino Twist Steerable Guiding Sheath DST0705517Oscor Inc. · INTRODUCER, CATHETER2 reports
- Destino Twist Steerable Guiding Sheath DST0855517Oscor Inc. · INTRODUCER, CATHETER2 reports
- Destino Twist Steerable Guiding Sheath DST0856517Oscor Inc. · INTRODUCER, CATHETER2 reports
- Destino Twist Steerable Guiding Sheath DST1209030Oscor Inc. · INTRODUCER, CATHETER2 reports
- Destino Twist Steerable Guiding Sheath DST1207122Oscor Inc. · INTRODUCER, CATHETER2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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