HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
- Company
- Boston Scientific Corporation
- Recall Initiated
- October 21, 2021
- Recall Number
- Z-0326-2022
- Firm Location
- Marlborough, MA
Reason for Recall
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Distribution
US Nationwide distribution.
Lot / Code Info
Batches: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, 27393787 GTIN: 08714729283867 Exp. 05/09/2022 to 05/27/2023
Root Cause
Device Design
Action Taken
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.