LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
Reported: December 16, 2015 Initiated: October 21, 2015 #Z-0384-2016
Product Description
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
Reason for Recall
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Details
- Recalling Firm
- LeMaitre Vascular, Inc.
- Units Affected
- 4315 total
- Distribution
- 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.
- Location
- Burlington, MA
Frequently Asked Questions
What product was recalled? ▼
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.. Recalled by LeMaitre Vascular, Inc.. Units affected: 4315 total.
Why was this product recalled? ▼
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2015. Severity: Moderate. Recall number: Z-0384-2016.
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