Recalls for Stent, Ureteral

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong.

Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.

Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.

"Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The bond may break where the two materials meet, resulting in separation of the stent.

The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.

The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.

The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.

The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.

The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.

The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.

Instructions on how to inject are not included in the package.

Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58.

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The radiographic band may detach from the stent and remain in the patient after removal of the stent.

Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.