LeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Read the official notice →- Date
- 2026-10-14
- Country
- United States
- Brand
- LeMaitre Vascular
- Product
- TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More LeMaitre Vascular recalls
- 2026-03-25
USLeMaitre Vascular, Inc. recalls Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
- 2025-10-29
- US
LeMaitre Vascular, Inc. recalls Artegraft¿ Collagen Vascular Graft; REF: AG1015;
The device was incorrectly packed in the wrong size labeled outer packaging.
- 2025-10-15
- US
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve…
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
FDA · DeviceLeMaitre Vascular, Inc.No US distribution. International distribution to Great Britian and Switzerland.Official notice → - 2025-10-08
- US
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8)…
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
FDA · DeviceLeMaitre Vascular, Inc.US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC,…Official notice → - 2025-05-21
- US
LeMaitre Vascular, Inc. recalls Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
FDA · DeviceLeMaitre Vascular, Inc.Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA,…Official notice → - 2024-05-22
- US
LeMaitre Vascular, Inc. recalls Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
The guide tip can become damaged and result in the tip detaching.
FDA · DeviceLeMaitre Vascular, Inc.Worldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice →
Other drugs & medical recalls in the United States
- 2026-10-14
- US
Intellijoint Surgical, Inc. recalls Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint…
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may…
FDA · DeviceIntellijoint Surgical, Inc.Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the…Official notice → - US
Steris Corporation recalls HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and…
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect…
FDA · DeviceSteris CorporationWorldwide - US Nationwide and the countries of Australia, Canada, New Zealand.Official notice → - US
Mindray DS USA, Inc. recalls ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- US
Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the state of ID.Official notice → - US
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting…
FDA · DevicePOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCWorldwide - US Nationwide distribution in the states and territory of AK, AR,…Official notice → - US
AVID Medical, Inc. recalls ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
Product may be potentially contaminated with a lubricant used during the manufacturing process.
FDA · DeviceAVID Medical, Inc.US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Official notice →