Class II U.S. Food and Drug Administration

Galt Medical Corporation Boston Scientific Enhance Transcarotid/Peripheral Access Kit recall: Black depth markings may detach from the outer sheath of the coaxial dilator

Recall published 2 months ago

Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2917-2026
Published
August 19, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Galt Medical Corporation
Product type
Medical devices
Units affected
114,260 kits
Distribution
Nationwide
Made in
United States
Lot / code info
UDI:00841268107250/Lot: 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 G23083106 G23083107 G23083108 G23083109 G23111110 G23111111 G23111112 G23111113 G23111114 G23111115 G23146116 G23146117 G23146118 G23146119 G23146121 G23146120 G23174122 G23174123 G23174124 G23174125 G23174126 G23174127 G23202128 G23202129 G23202130 G23202131 G23202132 G23202133 G23237134 G23237135 G23094468 G23237136 G23237137 G23237138 G23237139 G23237159 G23265140 G23265141 G23265142 G23265143 G23265144 G23265145 G23293146 G23293147 G23293148 G23293149 G23293150 G23293151 G23328152 G23328153 G23328154 G23328156 G24110621 G24110621 G24113622 G24113623 G24113625 G24113626 G24113624 G24036110 G24036113 G24036111 G24036111 G24036112 G24064115 G24064118 G24064118 G24064116 G24064116 G24064117 G24064119 G24064119 G24064120 G24064121 G24064122 G24092123 G24178931 G24092126 G24092127 G24092128 G24092129 G24127485 G24092125 G24092124 G24127486 G24127487 G24127488 G24127489 G24127490 G24127491 G24155492 G24155493 G24155494 G24155494 G24155495 G24155496 G24155497 G24155498 G24190499 G24190500 G24190501 G24190502 G24190503 G24190504 G24190505 G24190506 G24218507 G24218512 G24218509 G24218510 G24337696 G24337697 G24218508 G24337698 G24218511 G24246514 G24246515 G24246513 G24246517 G24246518 G24281519 G24281521 G24281520 G24281522 G24281523 G24246516 G24337699 G24281524 G24281525 G24281526 G24281527 G24309528 G24309529 G24309530 G24309532 G24309531 G24309533 G24309534 G24309535 G24337700 G24337701 G24337702 G24337703 G24337704 G25001012 G25008017 G25008013 G25008014 G25008015 G25008018 G25008016 G25008019 G25252905 G25252907 G25252906 G25273965 G25252910 G25294007 G25317082 G25318095 G25318096 G25318097 G25318094 G25318098 G25350169 G25350167 G25350170 G25353258 G25353259 G25350164 G22362193 G25350165 G25350171 G26016028 G26016029 G26016030 G26016031 G26016032 G26016033 G26016034 G26016035 G26044036 G26044039 G26044040 G26044041 G26044042 G26044043 G26044037 G26044038 G26099125 G26099126 G26099127 G26099128 G26099129 G26128429 G25252908 G25252909
UPC codes
00841268107250

Products covered by this recall

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

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00841268107250

Model or item number

On the rating label, the box or the instruction sheet.

  • SR-4F21G7D-MP

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Galt Medical Corporation — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Galt Medical Corporation — 2220 Merritt Dr, Garland, TX, 75041-6137

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Galt Medical Corporation medical devices recalled?

Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00841268107250; model number SR-4F21G7D-MP. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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