PlainRecordsFDA · Medical device recall
Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems… and 2 more products
- Date posted by the FDA
- April 22, 2003
- Status
- Terminated
- Filed by
- Boston Scientific Scimed
- Reason
- A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
- Distribution pattern
- Nationwide in the United States
3 products in this recall
Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems…
- Product
- Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400
- Quantity
- 1 Stent System
- Codes and lots
- Lot number 5350420
- Recall started
- March 17, 2003
- Device type
- Stent, Coronary
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots and return them.
- Recall number
- Z-0776-03
Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery…
- Product
- Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500301
- Quantity
- 4 Stent Systems
- Codes and lots
- Lot number 5357125
- Recall started
- March 17, 2003
- Device type
- Stent, Coronary
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots and return them.
- Recall number
- Z-0777-03
Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery…
- Product
- Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401
- Quantity
- 7 Stent Systems
- Codes and lots
- Lot number 5350197
- Recall started
- March 17, 2003
- Device type
- Stent, Coronary
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots and return them.
- Recall number
- Z-0778-03
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0776-03, Z-0777-03, Z-0778-03. The agency record governs; check it and the company before acting.