Recall Z-1026-2025
Boston Scientific Corporation · initiated December 20, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
Codes / lots: GTIN: 08714729951179 Lot Numbers: 32913258, 32914587, 32914588, 32914951, 32919344, 33161778, 33167722, 33167723, 33167724, 33168696, 33168697, 33217106, 33217107, 33223926, 33223927, 33224949, 33233462, 33234152, 33235720, 33235721, 33242497, 33242560, 33324868, 33333642, 33577901, 33577905, 33661063, 33677043, 33677044, 33677045, 33677046, 33677047, 33677048, 33680523, 33697485, 33767880, 33776935, 33776936, 33778737, 33778738, 33785758, 33785759, 33787022, 33787023, 33787024, 33787025, 33796610, 33804642, 34034896, 34034897, 34034898, 34037953, 34037954, 34037955, 34038584, 34038795, 34047362, 34047364, 34047365, 34074520, 34074521, 34093768, 34093769, 34101923, 34101924, 34126523, 34126524, 34128158, 34130337, 34134859, 34135080, 34136360, 33333648, 33470460, 33488331, 33509930, 33509931, 33509936, 33509937, 33510694, 33510695, 33517861, 33517862, 33568702, 33568703, 33571498, 33577559, 33577900, 33827339, 33883094, 33899654, 33902104, 33902106, 33908817, 33908818, 33908819, 33930901, 33931714, 33939630, 33998884, 33998885, 34004996, 34006717, 34027241, 34142867, 34144887, 34161824, 34161826, 34165830, 34165831, 34172977, 34172979, 34262100, 34307464, 34344894, 34356855…
Reason for recall
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.
FDA-determined cause: Process control
Action taken
Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required Letter via Fedex Priority Overnight on December 20, 2024 to US consignees. Letter states reason for recall, health risk and action to take: This removal affects only the products listed in Attachment 1. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Contact your local Boston Scientific representative with any questions.
Details
- Recall number
- Z-1026-2025
- Initiated
- December 20, 2024
- Posted by FDA
- January 29, 2025
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Quantity
- 1399 units; 20 units (OUS)
- Distribution
- Nationwide including Puerto Rico Foreign: To be provided
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1024-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1025-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1027-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1028-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1029-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1030-2025 Class II | AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1031-2025 Class II | AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1032-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1033-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1034-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1035-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1036-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |
| Z-1037-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | 12/20/2024Open, Classified |