Z-0773-2021Class II
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 -
Boston Scientific Corporation / initiated 2020-12-01 / Terminated / root cause: manufacturing process
Boston Scientific Corporation began a recall of AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and... on . FDA classified it as Class II and gives the reason as "The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0773-2021
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Boston Scientific Corporation
- Product
- AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- Product code
- PCU Pancreatic Stent, Covered, Metallic, Removable
- Reason for recall
- The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Boston Scientific issued customer notification letters to consignees via Federal Express Priority Overnight mail on December 1, 2020. The 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. Your local Sales Representative can answer any questions that you may have regarding this notification.
- Quantity in commerce
- 13 units
- Distribution
- US Nationwide distribution - Foreign: TBD.
- Product codes and lots
- Lot Number: 26134666 Exp. Date: 10/6/2022 GTIN:08714729904588
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0773-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0774-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0775-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0776-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0777-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0778-2021 | Class II | Terminated | Voluntary: Firm initiated |
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