Recall Z-1730-2020— Boston Scientific
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific, initiated 2020-03-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit. Reason: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device.
- Recalling firm
- Boston Scientific
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-03-09
- Firm location
- Marlborough, MA, United States
Product description
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
Reason for recall
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Data sourced from openFDA. This site is unofficial and independent of the FDA.