Oscor Inc. Recalls Destino Twist Steerable Guiding Sheath


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Destino Twist Steerable Guiding Sheath
Destino Twist Steerable Guiding Sheath

January 11, 2022 – Palm Harbor, FL., 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 on Tables 1, 2 and 3 below. 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.

TABLE 1: RECALLED PRODUCT IMPACTED

Product nameUDI NumberModelLot NumberExpiration DatePackaging State Type
Destino Twist 14F00885672011123DST1405525PQOC1347510-01-2024Sterile
Guidestar 14F00885692010911D141103DP1407311-01-2024Sterile
Guidestar 14F00885692010911D141103DP1407210-01-2024Sterile
Guidestar 14F00885692010911D141103DP1407110-01-2024Sterile
Guidestar 14F00885692010911D141103DP1383409-01-2024Sterile
Guidestar 14F00885692010911D141103DP1382809-01-2024Sterile
Guidestar 14F00885692010911D141103DP1382708-01-2024Sterile
Guidestar 14F00885692010911D141103PQOC1299507-01-2024Sterile
Guidestar 14F00885692010911D141103PQOC1263207-01-2024Sterile
Guidestar 14F00885692010911D141103PQOC1263307-01-2024Sterile
Guidestar 14F00885692010911D141103PQOC1234506-01-2024Sterile
Guidestar 14F00885692010911D141103PQOC1233006-01-2024Sterile

TABLE 2: DESTINO 14F TWIST MODEL

PRODUCT: Destino Twist 14F
GTIN (Unit)ModelSheath & DilatorFrench
Size
Quantity
00885672011123DST1405525S55CM D73CM14F6 Units

TABLE 3 GUIDESTAR 14F – MODEL

PRODUCT: Guidestar 14F
GTIN (Unit)ModelSheath & DilatorFrench
Size
Quantity
00885672010911D141103S71CM D89CM14F543 Units

 CUSTOMER MAY CONTACT:

Oscor Inc. is notifying its distributors and customers by email and is arranging for the return of all recalled products.

Customers with questions regarding this recall can contact Oscor’s Customer Relations Group, Monday to Friday from 8:30AM to 5:30PM Eastern Time at 727-937-2511 or via email at recall@oscor.com.

Healthcare professionals are encouraged to report any malfunction and/or adverse events related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Original recall and updates at FDA


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