| | Class 2 Device Recall TufTex OvertheWire Embolectomy Catheter |  |
| Date Initiated by Firm | April 11, 2025 |
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| Date Posted | May 12, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1750-2025 |
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| Recall Event ID |
96716 |
| 510(K)Number | K022145 |
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| Product Classification |
Catheter, embolectomy - Product Code DXE
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| Product | TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48,
1651-58, 1651-64, 1651-68, 1651-78,
1651-84, 1651-88, E1651-34, E1651-38,
E1651-44, E1651-48, E1651-64, E1651-68,
E1651-78, E1651-84, E1651-88, 1651-44J,
1651-48J, 1651-84J, 1651-88J. |
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| Code Information |
UDI-DI: 00840663100651, 00840663100668, 00840663100675, 00840663100682, 00840663100699, 00840663100705, 00840663100712, 00840663100729, 00840663107551, 00840663100736, 00840663100743, 00840663100750, 00840663100767, 00840663100774, 00840663100781, 00840663100798, 00840663100804, 00840663100811, 00840663100828, 00840663100835, 00840663107568, 00840663100842, 00840663100859, 00840663100866.
Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88.
Lots not expired with the following prefix: OTW, QOT, XOT, COT |
Recalling Firm/
Manufacturer |
LeMaitre Vascular, Inc.
32 3rd Ave
Burlington MA 01803-4414
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| For Additional Information Contact | Timothy Rodenberger
781-362-5449 Ext. 204 |
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Manufacturer Reason
for Recall | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
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FDA Determined
Cause 2 | Packaging process control |
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| Action | LeMaitre notified OUS consignees beginning on 04/11/2025, and US consignees on 04/23/2025 via email and letter. Consignees were instructed to not use the devices, immediately quarantine any on hand, and complete and return the response form. Once received a LeMaitre Vascular representative will contact customers to provide return instructions. If the products were transferred or further distributed, customers were instructed to notify those customers and provide a copy of the recall letter. |
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| Quantity in Commerce | 237,611 units |
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| Distribution | Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORTH MACEDONIA, NORWAY, OMAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKIYE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = DXE
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