Z-0646-2022Class II

Destino Twist 14F (also branded as Guidestar 14F)

Name: Z-0646-2022 Destino Twist 14F (also branded as Guidestar 14F)
Creator: Oscor Inc.
Published: 2021-12-22
License: https://open.fda.gov/license/

Oscor Inc. / initiated 2021-12-22 / Completed / root cause: manufacturing process

FDA source

Oscor Inc. began a recall of Destino Twist 14F (also branded as Guidestar 14F) on 2021-12-22. FDA classified it as Class II and gives the reason as "There is potential for separation between the threaded hub and threaded cap at the proximal end of the device". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0646-2022
Classification: Class II
Status: Completed
Initiated: 2021-12-22
Posted: 2022-02-17
Recalling firm: Oscor Inc.
Product: Destino Twist 14F (also branded as Guidestar 14F)
Product code: DYB Introducer, Catheter
Reason for recall: There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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].
Quantity in commerce: 549 units
Distribution: Distribution to TN and PA in USA OUS distribution to Czech Republic
Product codes and lots: 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]

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0646-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0646-2022	Class II	Completed	Voluntary: Firm initiated	2022-02-23	2022-02-17

Product code DYB

K140406Class IIDestino Twist, Steerable Guiding SheathOscor, Inc. / cleared 2014-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)