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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the…"
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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