FDA Medical Device Recalls (openFDA)
Boston Scientific Scimed: Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
- Recall number
- Z-0032-04
- Recalling firm
- Boston Scientific Scimed
- Product
- Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
- Status
- Terminated
- Initiated
- 2003-08-20
- Posted
- 2003-10-15
- Terminated
- 2005-10-24
- Reason
- Some of the recalled catheters have a component that has levels of pyrogens above specification.
- Root cause
- Other
- Action
- 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.
- Quantity
- 2 catheters
- Distribution
- The recalled products were distributed to consignees located nationwide in the United States.
- Lot, serial or model codes
- Lot 5707453
- 510(k) numbers
- not on file
- PMA numbers
- ["P860019"]
- Product code
- LOX
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28