Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Enhance Transcarotid/Peripheral Access Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Boston Scientific Enhance Transcarotid/Peripheral Access Kitsee related information
Date Initiated by FirmJune 26, 2026
Date PostedAugust 07, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2917-2026
Recall Event ID 99369
510(K)NumberK000737 K021990 
Product Classification Wire, guide, catheter - Product Code DQX
ProductBoston 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
Code Information 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
FEI Number 3000718472
Recalling Firm/
Manufacturer		 Galt Medical Corporation
2220 Merritt Dr
Garland TX 75041-6137
For Additional Information ContactCorrections Coordinator
214-778-1433
Manufacturer Reason
for Recall		Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn July 30, 2026, Galt Medical Issued a 4th iteration of the Urgent: Medical Device Recall Notification via Email expanding the affected lots. The initial notification was issued on June 26, 2026 via Email, 2nd notification issued on June 30, 2026 and 3rd notification issued on July 9, 2026. Galt Medical asked consignees to take the following actions 1. Discontinue use and distribution of the products with the affected lot numbers. 2. Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers. 3. Ensure all applicable personnel within the vicinity of device activation carefully read the content of this notification. If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification 4. Complete the enclosed Field Correction Reply Forms and email or fax them to the attention of the Corrections Coordinator at quality@galtmedical.com or 214-778-1433. 5. For additional details, see recall notification.
Quantity in Commerce114,260 kits
DistributionUS Nationwide distribution in the state of MN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DQX
510(K)s with Product Code = DQX
-
-