| Class 2 Device Recall Boston Scientific | |
Date Initiated by Firm | October 21, 2021 |
Create Date | December 01, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0320-2022 |
Recall Event ID |
88991 |
510(K)Number | K130484 |
Product Classification |
Stents, drains and dilators for the biliary ducts - Product Code FGE
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Product | HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.
UPN: M00545890 |
Code Information |
GTIN: 08714729283805
Lot Numbers:
25612668, 25649812, 25704208, 25771760, 25878552, 26000695, 26010387, 26058284, 26087172, 26087173, 26123181, 26324742, 26366746, 26406513, 26429808, 26499853, 26527374, 26573853, 26638827, 26651718, 26665448, 26893604, 27026984, 27074109, 27145234, 27162321, 27255235, 27306699.
Exp. 05/19/2022 to 05/13/2023
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Recalling Firm/ Manufacturer |
Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752-1234
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For Additional Information Contact | Rebecca Kinkead Rubio 763-494-1133 |
Manufacturer Reason for Recall | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
FDA Determined Cause 2 | Device Design |
Action | Boston Scientific issued Urgent Medical Device Removal Letter to US consignees via Federal Express Priority Overnight mail on October 21, 2021. Letter states reason for recall, health risk and action to take:
Cease further distribution or use of any remaining product affected by this
removal immediately.
Verify by product lot/batch number in the product table whether any product within your
inventory is affected. If so, indicate on your Reply Verification Tracking Form the
quantity of units from each lot/batch that you will be returning.
If you identify any product from the affected lots/batches within your inventory, please
segregate the product immediately and return it to BSC in accordance with the enclosed
instructions. If you are a distributor, please note that the depth of this removal is to
the end user level and this notification should be forwarded to your customers. If
you are a facility that has sent products to another hospital or facility within your
network, please ensure that this notification is forwarded to them.
Please read carefully through the removal instructions included with this notification.
Your local Sales Representative can answer any questions that you may have
regarding this notification. |
Distribution | US Nationwide distribution.
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = FGE
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