CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report
Direxion Torqueable Microcatheter, Ngmc/Single/021/Bern/1RO/105 recalled
Boston Scientific Cork is recalling Direxion Torqueable Microcatheter, Ngmc/Single/021/Bern/1RO/105, distributed nationwide in the US. The recall was initiated on 16 Sep 2026 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-0226-2027
- FDA event ID
- 99906
- Recalling firm
- Boston Scientific Cork, Cork
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Sep 2026
- FDA classified
- 22 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 16 Sep 2026 | Recall initiated by company | |
| 22 Oct 2026 | Classified by FDA | +36 days |
| 28 Oct 2026 | 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
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230
Where it was distributed
Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.
Questions about this recall
Why was it recalled?
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Which lots are affected?
Material Number: M001195230; UDI-DI: 08714729839347; Batch Numbers: 37818205, 37942458, 37956675, 37981346, 38002441, 38224529, 38224530, 38304917, 38304918, 38415912, 38484288, 38506191, 38595896, 38629330, 38647611, 38647613, 38687220, 38687221, 38707976, 38876166, 38970274, 38970936, 39092279, 39092680, 40484896, 40484897, 40484952, 40523918, 40523919, 40525673, 40525674, 40525675, 40525676, 40531394, 40531395, 40531396;
Where was it sold?
Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.
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 3 Nov 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
40 other products · FDA event 99906This product is part of a recall event; the main page for the event is Direxion Torqueable Microcatheter, Ngmc/Single/021/Swan/1RO/105 recalled.
More recalls from Boston Scientific Cork
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Fathom/027/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/155 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/J/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,268| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Fathom/027/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/155 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/J/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |