CLASS II ONGOING Device recall · Reported 16 Jul 2025 · FDA Enforcement Report
VersaCross Transseptal Sheath Kit recalled by Boston Scientific
Boston Scientific is recalling VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS/45DEG/D0, distributed nationwide in the US. The recall was initiated on 10 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2105-2025
- FDA event ID
- 97036
- Recalling firm
- Boston Scientific, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jun 2025
- FDA classified
- 10 Jul 2025
- Reported
- 16 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 10 Jun 2025 | Recall initiated by company | |
| 10 Jul 2025 | Classified by FDA | +30 days |
| 16 Jul 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Questions about this recall
Why was it recalled?
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Which lots are affected?
VXS0201 UDI-DI 00685447020301 Lot 35800622; VXS2112 UDI-DI 00685447019251 Lot 35892045
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 97036This product is part of a recall event; the main page for the event is Torflex Transseptal Guiding Sheath Kit recalled by Boston Scientific.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Torflex Transseptal Guiding Sheath Kit recalled by Boston Scientific | Boston Scientific | Sterility | Nationwide | |
| CLASS II | VersaCross Access Solution (Vxsk), Product Description recalled | Boston Scientific | Sterility | Nationwide | |
| CLASS II | VersaCross RF Wire (VXW) recalled by Boston Scientific | Boston Scientific | Sterility | Nationwide |
More recalls from Boston Scientific
All 626| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS I | Enroute Transcarotid Neuroprotection System recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS I | Enroute Transcarotid Neuroprotection System Plus recalled | Boston Scientific | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |