Catheter, Embolectomy

Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310

A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.

TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48,

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

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.

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

TufTex Embolectomy Catheter, Model No.

Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.

Fogarty Arterial Embolectomy Catheters Model Number:

Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

Fogarty Biliary Balloon Probes Model Number:

Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR

7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR

7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR

7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.