Z-0778-2021Class II

Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 -

Name: Z-0778-2021 Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 -
Creator: Boston Scientific Corporation
Published: 2020-12-01
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-12-01 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60... on 2020-12-01. 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 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0778-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-01
Posted: 2021-01-06
Terminated: 2023-07-14
Recalling firm: Boston Scientific Corporation
Product: Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - 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: 78 units
Distribution: US Nationwide distribution - Foreign: TBD.
Product codes and lots: Lot Number: 26167277, 26171099, 26152171, 26171383, 26171380, 26152172 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0778-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0773-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-06
Z-0774-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-06
Z-0775-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-06
Z-0776-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-06
Z-0777-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-06
Z-0778-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-06

Product code PCU

K181905Class IIAXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation / cleared 2019-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)