LeMaitre Vascular, Inc.: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Agency Publication Date: December 4, 2015

Affected Products

Product: LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.

Lot Codes: OTW3094¿and OTW3098¿

Lot Numbers:

Codes

Product: LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.

Lot Numbers: OTW3080 OTW3080¿ OTW3081¿ OTW3083¿ OTW3100¿

Lot Numbers:

Numbers

Product: LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.

Lot Numbers: OTW3092¿OTW3084 OTW3084 (sample) OTW3087¿OTW3101¿

Lot Numbers:

Numbers

Product: LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.

Lot Numbers: OTW3092¿OTW3084 OTW3084 (sample) OTW3087¿OTW3101¿

Lot Numbers:

Numbers

Product: LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.

Lot Numbers: OTW3079 OTW3079 OTW3046¿ ¿

Lot Numbers:

Numbers

Product: LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.

Lot Numbers: OTW3103¿OTW3114¿OTW3119¿ ¿

Lot Numbers:

Numbers

Product: LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.

Lot Number: OTW3108¿

Lot Numbers:

Number

Product: LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.

Lot Number: OTW3099¿

Lot Numbers:

Number

Product: LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.

Lot Number: SLC3672¿SLC3663 SLC3663¿SLC3667¿

Lot Numbers:

Number

Product: LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.

Lot Number: SLC3636 SLC3636 (sample) SLC3636¿SLC3668 SLC3668¿SLC3669¿SLC3654¿ SLC3670¿

Lot Numbers:

Number

Product: LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.

Lot Number: SLC3673¿SLC3637 SLC3637¿SLC3666 SLC3676¿SLC3689¿

Lot Numbers:

Number

Product: LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.

Lot Number: NSE1663

Lot Numbers:

Number

Product: LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.

Lot Number: NSE1658¿

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72534

Status: Resolved

Manufacturer: LeMaitre Vascular, Inc.

Manufactured In: United States

Units Affected: 13 products (4315 total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.

Lot Codes: OTW3094¿and OTW3098¿

Lot Numbers:

Codes

Product: LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.

Lot Numbers: OTW3080 OTW3080¿ OTW3081¿ OTW3083¿ OTW3100¿

Lot Numbers:

Numbers

Product: LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.

Lot Numbers: OTW3092¿OTW3084 OTW3084 (sample) OTW3087¿OTW3101¿

Lot Numbers:

Numbers

Product: LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.

Lot Numbers: OTW3092¿OTW3084 OTW3084 (sample) OTW3087¿OTW3101¿

Lot Numbers:

Numbers

Product: LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.

Lot Numbers: OTW3079 OTW3079 OTW3046¿ ¿

Lot Numbers:

Numbers

Product: LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.

Lot Numbers: OTW3103¿OTW3114¿OTW3119¿ ¿

Lot Numbers:

Numbers

Product: LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.

Lot Number: OTW3108¿

Lot Numbers:

Number

Product: LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.

Lot Number: OTW3099¿

Lot Numbers:

Number

Product: LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.

Lot Number: SLC3672¿SLC3663 SLC3663¿SLC3667¿

Lot Numbers:

Number

Product: LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.

Lot Number: SLC3636 SLC3636 (sample) SLC3636¿SLC3668 SLC3668¿SLC3669¿SLC3654¿ SLC3670¿

Lot Numbers:

Number

Product: LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.

Lot Number: SLC3673¿SLC3637 SLC3637¿SLC3666 SLC3676¿SLC3689¿

Lot Numbers:

Number

Product: LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.

Lot Number: NSE1663

Lot Numbers:

Number

Product: LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.

Lot Number: NSE1658¿

Lot Numbers:

Number