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4 months ago
Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal on the proximal end of the device handle detaching during use.

RISK STATEMENT: The Destino Twist 14T Model DST1405525 & Guidestar 14F Model D141103 detachment of the hub cap and seal could lead to bleeding at the proximal end of the device and/or air embolism for the patient during intracardiac, renal or other peripheral placements procedures.

Oscor Inc. has reported two (2) Medical Device Reports to the FDA related to detachment of hub cap and seal on the proximal end of the device handle. The recall is limited to the two model numbers and lot numbers outlined above. There are no other recalls associated with this product.

PRODUCT INFORMATION: The product is steerable guiding sheath intended for the introduction of diagnostic and therapeutic devices into the human vascular, including but not limited to intracardiac, renal or other peripheral placements; it cannot be use for neural placements. The product is provided sterile, one unit per pouch / tray for details and can be identified on the printed labeling with the information below (1, 2, and 3).

The affected Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 were distributed Worldwide to distributors and hospitals from June 8, 2021 to November 30, 2021.

Recalled Product Impacted (1)

- Destino Twist 14F (DST1405525). UDI Number: 885672011123. Lot Number: PQOC13475. Expiration Date 10-01-2021. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14073. Expiration Date 11-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14072. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14071. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13834. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13828. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13827. Expiration Date 08-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12995. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12632. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12633. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12345. Expiration Date 06-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12330. Expiration Date 06-01-2025. Packaging State Type: Sterile.

Destino 14F Twist Model (2)

Product: Destino Twist 14F
GTIN (Unit): 00885672011123
Model: DST1405525
Sheath & Dilator: S55CM D73CM
French Size: 14F
Quantity: 6 Units

Guidestar 14F - Model (3)

Product: Guidestar 14F
GTIN (Unit): 00885672010911
Model: D141103
Sheath & Dilator: S71CM D89CM
French Size: 14F
Quantity: 543 Units

Company name: Oscor Inc.
Brand name: Oscor
Recalled: Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 steerable guiding sheath
Reason of the recall: Hub cap and seal on the proximal end of the device handle may detach during use
FDA Recall date: January 12, 2022

Check the full recall details on fda.gov

Source: FDA
#medicaldevices #recall #unitedstates
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