PlainRecordsFDA · Medical device recall
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation… and 2 more products
- Date posted by the FDA
- Oct. 15, 2003
- Status
- Terminated
- Filed by
- Boston Scientific Scimed
- Reason
- Some of the recalled catheters have a component that has levels of pyrogens above specification.
- Distribution pattern
- The recalled products were distributed to consignees located nationwide in the United States.
3 products in this recall
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon…
- Product
- Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
- Quantity
- 9 catheters
- Codes and lots
- Lot 5689062
- Recall started
- Aug. 20, 2003
- Device type
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them.
- Recall number
- Z-0030-04
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon…
- Product
- Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
- Quantity
- 6 catheters
- Codes and lots
- Lots 5685024 and 5685027
- Recall started
- Aug. 20, 2003
- Device type
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them.
- Recall number
- Z-0031-04
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon…
- Product
- Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
- Quantity
- 2 catheters
- Codes and lots
- Lot 5707453
- Recall started
- Aug. 20, 2003
- Device type
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them.
- Recall number
- Z-0032-04
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0030-04, Z-0031-04, Z-0032-04. The agency record governs; check it and the company before acting.