Device recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Class II FDA enforcement event 96049. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Boston Scientific Corporation started this device recall on 20 Dec 2024. The firm address in the FDA record is in Marlborough, MA. FDA put the recall in Class II. FDA event 96049 has 14 product records. The first FDA enforcement report date is 5 Feb 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide including Puerto Rico Foreign: To be provided
Recalling firm
Boston Scientific Corporation, Marlborough, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
14 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1024-2025 | AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640 | 495 units US; 2 units(OUS) | Class II | Ongoing | 5 Feb 2025 |
| Z-1025-2025 | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650 | 1144 units US; 60 units (OUS) | Class II | Ongoing | 5 Feb 2025 |
| Z-1026-2025 | AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660 | 1399 units; 20 units (OUS) | Class II | Ongoing | 5 Feb 2025 |
| Z-1027-2025 | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670 | 309 units | Class II | Ongoing | 5 Feb 2025 |
| Z-1028-2025 | AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680 | 31 units | Class II | Ongoing | 5 Feb 2025 |
| Z-1029-2025 | AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690 | 47 units | Class II | Ongoing | 5 Feb 2025 |
| Z-1030-2025 | AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740 | 12 units | Class II | Ongoing | 5 Feb 2025 |
| Z-1031-2025 | AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 | 38 units | Class II | Ongoing | 5 Feb 2025 |
| Z-1032-2025 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520 | 263 units (OUS) | Class II | Ongoing | 5 Feb 2025 |
| Z-1033-2025 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530 | 91 units (OUS) | Class II | Ongoing | 5 Feb 2025 |
| Z-1034-2025 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540 | 519 units (OUS) | Class II | Ongoing | 5 Feb 2025 |
| Z-1035-2025 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550 | 1530 units (OUS) | Class II | Ongoing | 5 Feb 2025 |
| Z-1036-2025 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560 | 1102 units (OUS) | Class II | Ongoing | 5 Feb 2025 |
| Z-1037-2025 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570 | 118 units (OUS) | Class II | Ongoing | 5 Feb 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 14Median of the firm: 2
- Events of the firm on the register
- 162
Other events of the firm
Official channels
- FDA enforcement report Z-1024-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 96049. https://recallregister.com/fda/ii/96049/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide including Puerto Rico Foreign: To be provided
- What quantity of product is in FDA event 96049?
- The event has 14 product records. The first record gives this quantity:
495 units US; 2 units(OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.