FDA recall, , Moderate risk
Galt Medical Boston Scientific Enhance Transcarotid/Peripheral Access Kit
The Enhance Transcarotid/Peripheral Access Kit has black depth markings that may detach from the outer sheath.
Summary by Recall Canary from the FDA notice
What happened
Galt Medical Corporation, based in Garland, Texas, recalled the Boston Scientific Enhance Transcarotid/Peripheral Access Kit because black depth markings may detach from the outer sheath of the coaxial dilator introducer component. The recall began June 26, 2026, and was added to the FDA's Enforcement Report on August 7, 2026.
The affected product is the Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator, Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock. Distribution was in Minnesota.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
Incomplete list: 40 of 231 lot codes shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
- UDI-DI
- 00841268107250
- Lot code
- G22171212
- G22201213
- G22201214
- G22201215
- G22201216
- G22201217
- G22201218
- G22234219
- G22234220
- G22262227
- G22234221
- G22234222
- G22234223
- G22262225
- G22234224
- G22262226
- G22262228
- G22262229
- G22262230
- G22292231
- G22292232
- G22292233
- G22292234
- G22292235
- G22292236
- G22292237
- G22320238
- G22320239
- G22320240
- G22320241
- G22320242
- G22320243
- G22320244
- G22354191
- G22362192
- G22362194
- G22362195
- R23083454
- G23076104
- G23076105
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Minnesota.
- Company
- Galt Medical CorporationGarland, Texas
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99369
- Recall number
- Z-2917-2026
- Quantity recalled
- 114,260 kits
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
