Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72534

13 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 21, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
LeMaitre Vascular, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

13 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 13

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

Z-0378-2016
Recall number
Z-0378-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Codes: OTW3094¿and OTW3098¿

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 2 of 13

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

Z-0379-2016
Recall number
Z-0379-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 3 of 13

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

Z-0380-2016
Recall number
Z-0380-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 4 of 13

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

Z-0381-2016
Recall number
Z-0381-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 5 of 13

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

Z-0382-2016
Recall number
Z-0382-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: OTW3079 OTW3079 OTW3046¿ ¿

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 6 of 13

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

Z-0383-2016
Recall number
Z-0383-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: OTW3103¿OTW3114¿OTW3119¿ ¿

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 7 of 13

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

Z-0384-2016
Recall number
Z-0384-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Number: OTW3108¿

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 8 of 13

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

Z-0385-2016
Recall number
Z-0385-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Number: OTW3099¿

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 9 of 13

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

Z-0386-2016
Recall number
Z-0386-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Number: SLC3672¿SLC3663 SLC3663¿SLC3667¿

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 10 of 13

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

Z-0387-2016
Recall number
Z-0387-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 11 of 13

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

Z-0388-2016
Recall number
Z-0388-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 12 of 13

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

Z-0389-2016
Recall number
Z-0389-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Number: NSE1663

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

device · product 13 of 13

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

Z-0390-2016
Recall number
Z-0390-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Number: NSE1658¿

Distribution pattern

Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

Field note

Send feedback

We'll only use this to respond to your feedback.