Boston Scientific Recalls Fetch 2 Aspiration Catheters Due to Shaft Breaks
Boston Scientific is recalling Fetch 2 Aspiration Catheters because the catheter shafts may break, potentially requiring additional procedures to remove the broken piece from patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect (shaft break) that poses a risk of harm requiring additional intervention, but the source text does not report specific injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling all models of the Fetch 2 Aspiration Catheter, Catalog No. 109400-001. The recall affects 21,155 units distributed worldwide, including the United States (excluding Delaware, Idaho, South Dakota, and Wyoming) and numerous international markets.
The recall was initiated after the company received field reports of catheter shaft breaks. In some instances, the broken shaft required the use of a snare or other medical intervention to retrieve the fragment from the patient.
Healthcare providers and patients should stop using the affected devices and contact Boston Scientific for further instructions on retrieval or replacement. The specific lot numbers affected are listed in the official FDA recall record.
The recalled product
- Product
- Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 21,155
Distribution
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