Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)

FDA device recall Z-1735-2020 · posted 2020-04-01 · Open, Classified

Recall details

Recalling firm

Boston Scientific

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

Action taken

Boston Scientific issued Customer Notification on March 9, 2020 stating reason for recall, health risk and action to take: cease distribution or use of any remaining product affected by this removal should cease immediately; Verify by product lot/batch number in the product table whether any product within your inventory is affected. If so, indicate on your Verification Form the quantity of units from each lot/batch that you will bereturning. As some of these products within these lots/batches are sold as 5-packs, it is important that all reported quantities represent the actual number of single units being returned and not the number of cartons/boxes or multi-packs; If you identify any product from the affected lots/batches within your inventory, please segregate the product immediately and return it to BSC in accordance with the enclosed instructions. If you are a distributor, please note that the depth is to the hospital level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital within your network, please ensure that this notification is forwarded to them.

Root cause

Component change control

Status

Open, Classified

Product code

EZB

Quantity affected

5 units

Distribution

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

Date initiated

2020-03-09

Date posted

2020-04-01

Location

Marlborough, MA