CLASS II ONGOING Device recall · Reported 16 Jul 2025 · FDA Enforcement Report
Torflex Transseptal Guiding Sheath Kit recalled by Boston Scientific
Boston Scientific is recalling Torflex Transseptal Guiding Sheath Kit (Tfk-m) TF85-32-63-45 Torflex 8.5F 45DEG, 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-2106-2025
- 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
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG 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?
TF85-32-63-45 UDI-DI 00685447005391 Lots 35508747 35644132 35746496 35913449; TF85-32-63-55 UDI-DI 00685447005407 Lots 35508748 35738145
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 97036| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 | |
| CLASS II | VersaCross Transseptal Sheath Kit recalled by Boston Scientific | Boston Scientific | Sterility | Nationwide |
More recalls from Boston Scientific
All 628| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | StoneSmart Connect Console Contents: Power Cord recalled | Boston Scientific | Other | 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 II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |